For FDA approval, a Malaysian manufacturer usually needs 510(k) clearance, and that includes medical gloves, which are Class I but still need a 510(k). FDA decides on your evidence rather than your MDA registration, and every device also needs establishment registration, device listing and a US Agent before import.
Key takeaways
- FDA cleared 58 510(k)s from Malaysian applicants from January 2023 to September 2026, and 50 of them were gloves. Malaysia had more nitrile exam glove clearances than any other country: 41 of 130.
- Exam gloves and surgeon's gloves are Class I, but both need a 510(k). Among exam gloves, only finger cots are exempt. Powdered medical gloves are banned in the US.
- Malaysian nitrile exam glove 510(k)s took a median of 153 days to clear, against 92 days for Chinese and 97 for US applicants. Glove 510(k)s can use third-party review, which took a median of 31.5 days.
- FDA's import alert for medical gloves lists 42 manufacturers or shippers in Malaysia. One failed sample can be enough for FDA to recommend detaining a firm's future shipments without examination.
- The FY2027 510(k) fee is $28,653, or $7,163 for a small business. A Malaysian company qualifies with a certification from its national tax authority.
How many Malaysian devices does FDA clear, and which kinds?
We counted every 510(k) that FDA cleared from January 3, 2023 to September 27, 2026, using FDA's public 510(k) data [1]. Applicants in Malaysia received 58 clearances, 0.5% of all 12,058. Malaysia ranked 22nd by country, close to Singapore (61) and Belgium (44).
The 58 clearances went to 32 companies. There were 29 in 2023, 7 in 2024 and 10 in 2025. 2026 is running ahead of 2025, with 12 clearances to the end of September against 9 in the same months of 2025 [1].
Gloves dominate [1]:
| Device type (product code) | Malaysian clearances |
|---|---|
| Polymer patient examination gloves, mostly nitrile (LZA) | 41 |
| Surgeon's gloves (KGO) | 7 |
| Latex patient examination gloves (LYY) | 2 |
| Balloon retention catheters (EZL) | 2 |
| Six other device types, one each | 6 |
For polymer exam gloves, Malaysia led the world. It had 41 of the 130 clearances in the period, ahead of China (35) and the US (35). It also had the most surgeon's glove clearances: 7 of 19 [1].
FDA's registration data shows a second side of Malaysian manufacturing. On October 13, 2026, 252 Malaysian sites were registered with FDA. More of them were registered as contract manufacturers (147) than as manufacturers of their own devices (143) [2]. Among the most common Malaysian listings with no 510(k) number are polymer exam gloves, bone screws, specialty gloves, bone plates and knee implants [2]. Contract manufacturers must register and list too, even when another company owns the design [4].
Our method: we counted cleared decisions where the applicant's address is in Malaysia. The applicant is usually the manufacturer. A Malaysian company that files through a US subsidiary is counted under the US.
Does an MDA registration help with FDA clearance?
Not directly. FDA does not accept a Medical Device Authority (MDA) registration in place of a 510(k). The 510(k) rules apply to every company that must register with FDA, wherever it is [4]. FDA makes its own decision on your evidence.
What can carry over is the evidence behind your registration:
- Test reports. FDA accepts reports from Malaysian labs if they meet its expectations, such as testing to the FDA-recognized version of each standard. The testing section below covers this.
- Your quality system. A working ISO 13485 system is a strong base for FDA's quality rules. Our QMSR guide explains what FDA expects.
What does not carry over is your comparison device. A 510(k) must compare your device to a predicate that is legally marketed in the US [4]. A device sold only in Malaysia cannot be your predicate. For the full picture, and for how Malaysia treats an FDA clearance in the other direction, see our guide to what an MDA registration does and does not change.
Do medical gloves need a 510(k)?
Yes. This is the most important misconception for Malaysian manufacturers. Patient examination gloves and surgeon's gloves are both Class I devices. Many Class I devices are exempt from a 510(k), but these are not. For exam gloves, the regulation exempts only finger cots [4]. FDA's classification database lists surgeon's gloves, polymer and latex exam gloves, and specialty gloves as needing a 510(k) [11].
Four more glove rules to know:
- Powdered gloves are banned. FDA bans powdered surgeon's gloves and powdered patient examination gloves [4]. A non-powdered glove may contain only residual powder from manufacturing [4].
- Specialty claims change the product code. Gloves claimed to protect against fentanyl and other opioids have their own product code (QDO). Unlike standard exam gloves, they are not eligible for third-party review [11].
- Latex gloves need a caution statement. Devices with natural rubber latex that contacts people must carry the statement "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions" in bold. Their labeling must not use the word "hypoallergenic" [4].
- FDA tests gloves at the border. FDA checks glove samples for leaks with a 1,000 ml water test. A lot is adulterated if defects reach the reject number for a 1.5 acceptable quality level (AQL) for surgeon's gloves or 2.5 AQL for exam gloves [4].
Some other devices are exempt. Check your device's product code in FDA's classification database before you plan a 510(k) [11]. Exemptions also have limits, set out in each classification part, such as 21 CFR 880.9 for hospital devices [4]. Our device classification guide explains how to read an entry.
What testing does a glove 510(k) need, and does FDA accept Malaysian labs?
We read the 510(k) summaries for the 24 polymer exam glove (LZA) 510(k)s cleared in 2025 that had a summary in FDA's database. This is how many cited each standard [1]:
| Standard cited | What it covers | Summaries citing it (of 24) |
|---|---|---|
| ASTM D6319 | Specification for nitrile examination gloves | 20 |
| ASTM D5151 | Detection of holes in medical gloves | 20 |
| ASTM D6978 | Permeation by chemotherapy drugs | 19 |
| ASTM D6124 | Residual powder on medical gloves | 18 |
| ISO 10993-10 | Biocompatibility: skin sensitization | 18 |
| ISO 10993-11 | Biocompatibility: systemic toxicity | 16 |
| ISO 10993-23 | Biocompatibility: irritation | 11 |
| ISO 10993-5 | Biocompatibility: cytotoxicity | 10 |
Most of these glove 510(k)s went beyond the basic specification. 19 of the 24 cited the chemotherapy drug permeation test. Check every standard's FDA-recognized version in FDA's Recognized Consensus Standards database before testing starts.
FDA accepts test reports from Malaysian labs. What counts is the standard and version you tested to, the completeness of the report and how the study was run, not where the lab is. Three points matter most:
- No ASCA labs in Malaysia yet. On October 12, 2026, FDA's ASCA program listed 98 accredited labs, and none were in Malaysia [10]. For biocompatibility, an ASCA summary report can replace a complete test report in some cases [12]. Without an ASCA lab, plan to submit complete biocompatibility test reports [12].
- Lab accreditation is not GLP. For biocompatibility, FDA recommends a statement that the studies followed its Good Laboratory Practice rules in 21 CFR Part 58 [12]. FDA notes it does not recognize ISO/IEC 17025 accreditation for this purpose [12].
- English. All content must be in English, including any translated reports [6].
Our guide to using foreign test reports in a 510(k) covers the full rules.
What are the steps from Malaysia to the US market?
For a device that needs a 510(k), the usual order is:
- Confirm the classification. Find the product code, regulation number and class. If you cannot tell, you can ask FDA through a 513(g) request. Its FY2027 fee is $8,596, or $4,298 for a small business [3].
- Choose a predicate. Pick a device legally marketed in the US with the same intended use. For gloves, there are many recent predicates. Search FDA's 510(k) database by product code. Our predicate guide explains how.
- Plan and run the testing. Test to the FDA-recognized version of each standard, at a lab in Malaysia or elsewhere.
- Request small business status early. If your company and its affiliates had gross receipts of no more than $100 million, apply at least 60 days before the 510(k) fee is due [3].
- Choose the review route. Glove product codes LZA, LYY, KGO and LZC are eligible for third-party review [11]. A third-party review has no FDA 510(k) fee; you pay the review organization instead [9]. Our third-party review guide explains the route.
- Build the submission in eSTAR. FDA has required eSTAR for 510(k)s since October 1, 2023 [5].
- Pay the fee and submit. For a standard FDA review, FDA must receive the correct fee when you submit, or it will not accept the 510(k) [3]. FDA then has 15 calendar days for its acceptance review [6].
- Answer FDA's questions. If FDA sends an Additional Information request, the review goes on hold. You have up to 180 calendar days to send a complete response, or FDA considers the 510(k) withdrawn [7].
- Receive the clearance letter. Your device is cleared, not approved. Approval is the word for PMA devices.
- Register, list and name a US Agent. Do this before the device is imported. The sections below cover timing and cost, and our importing guide covers customs entry.
What does FDA clearance cost a Malaysian manufacturer?
FDA's fees for fiscal year 2027 apply from October 1, 2026 to September 30, 2027 [3]:
| FDA fee (FY2027) | Standard | Small business |
|---|---|---|
| 510(k) | $28,653 | $7,163 |
| 513(g) request for classification | $8,596 | $4,298 |
| De Novo request | $191,020 | $47,755 |
| Annual establishment registration | $13,785 | $13,785 |
The small business rate cuts the 510(k) fee by three quarters. To get it, a company outside the US sends FDA a MDUFA Small Business Request form and a certification from its national tax authority. For a Malaysian company, that is the Inland Revenue Board of Malaysia (LHDN). The certification must show gross receipts for the most recent tax year in both US dollars and ringgit, the exchange rate used and the dates covered. Each affiliate needs its own certification [3]. For a company in a large glove group, affiliates' receipts count toward the $100 million limit.
Small business status lasts one fiscal year. Status for FY2026 ended on September 30, 2026, so you must qualify again for FY2027 [3]. Our small business guide walks through the request.
The annual registration fee has no small business rate. FDA may waive it only for a business with no more than $1 million in gross receipts on its most recent US federal tax return [3].
FDA fees are only part of the budget. The real cost drivers are:
- Testing. Its scope depends on your claims. Each added claim, such as chemotherapy drug or opioid protection, adds tests.
- Repeat work. Tests to the wrong standard version, or a weak response to FDA's questions, add cost and time.
- Detained shipments. A glove lot that fails FDA's sampling can be detained, and later shipments can face detention too.
- US roles. You will pay a US Agent, and you may pay an advisor.
Use our FDA user fees page to check the current rates before you budget.
How long does FDA clearance take for Malaysian manufacturers?
Malaysian Traditional 510(k)s cleared from January 2023 to September 2026 took a median of 156.5 days from FDA's receipt to clearance. A quarter cleared within 95 days, and a quarter took 220 days or more [1]. The median for all applicants was 151 days.
That looks close to average, but the device mix hides the gap. Gloves usually clear faster than most devices. Compared with the median for the same device types, Malaysian 510(k)s took about 34% longer [1]. Our review times by country analysis has the full method.
The glove numbers show it most clearly. For polymer exam gloves with a standard FDA review, the medians were [1]:
| Applicant country | Polymer exam glove 510(k)s (LZA) | Median days |
|---|---|---|
| Malaysia | 33 | 153 |
| China | 31 | 92 |
| United States | 17 | 97 |
| Vietnam | 6 | 91.5 |
| All applicants | 92 | 103 |
FDA's review goal counts only FDA's own days. Its clock stops while it waits for your answers, and it starts only once FDA accepts the file [7]. So much of a long total is time on hold. That puts the fastest lever in your hands: a complete eSTAR and quick, complete answers to FDA's questions.
Two faster routes exist. Only 4 of the 130 polymer exam glove clearances used third-party review, and they took a median of 31.5 days from FDA's receipt [1]. FDA aims to decide within 30 days of receiving the review organization's recommendation. The organization's own review comes before that [9]. Special 510(k)s, for changes to your own cleared device, took a median of 48 days for Malaysian applicants, across 7 clearances [1].
When do you need a US Agent and FDA registration?
Not before your 510(k). You can submit a 510(k) and receive clearance before you register. But no device may be imported into the US unless its maker's site is registered and the device is listed [4].
The rules for a Malaysian site [4]:
- Timing. Register within 30 days of starting the operation that requires registration, and list your devices at the same time.
- Fee first. Pay the annual registration fee before you register. A site is not legally registered until it has registered and paid [3].
- One US Agent. Name one US Agent who lives or has a place of business in the US. FDA may contact the agent when it cannot reach you, and the agent helps schedule inspections. Report any change to the agent within 10 business days.
- Every year. Renew registration and review all listings between October 1 and December 31.
- English. Registration and listing information must be in English.
Gloves face one more step at the border. FDA's Import Alert 80-04 covers surgeon's and patient examination gloves. On October 13, 2026, it listed 42 manufacturers or shippers in Malaysia. Only China had more entries, with 149 [8]. FDA states that, because defective gloves are a potential hazard, one violative sample is enough to recommend detaining a firm's future glove shipments without physical examination. FDA also samples gloves from firms that are not on the list [8].
Complizen's US team handles establishment registration, device listing and the US Agent role for foreign manufacturers. Exempt devices can enter the US this way while a 510(k) for another device is still in progress.
What do Malaysian manufacturers get wrong?
Each of these mistakes breaks a clear FDA rule:
| Common mistake | What FDA actually requires |
|---|---|
| Assuming Class I gloves need no 510(k) | A 510(k) for exam and surgeon's gloves; only finger cots are exempt [4, 11] |
| Sending the MDA technical file as the 510(k) | A comparison to a US predicate, in the eSTAR format, in English [4, 5, 6] |
| Adding a chemotherapy or opioid claim late | Testing for each claim, and the right product code for opioid protection gloves [11] |
| Using "hypoallergenic" on latex glove labels | No "hypoallergenic" claim, and the latex caution statement in bold [4] |
| Releasing lots at a lower quality level than FDA samples to | At least 1.5 AQL for surgeon's gloves and 2.5 AQL for exam gloves [4] |
| Paying the full 510(k) fee by mistake | A small business request, with an LHDN certification, at least 60 days before the fee is due [3] |
| Answering an FDA question late or in part | A complete response within 180 calendar days, or the 510(k) is withdrawn [7] |
What should you do next?
Start with your product code and your claims. They decide whether you need a 510(k), which standards apply and whether third-party review is open to you. Then compare your MDA file and test reports with what a 510(k) for that product code needs. Before you submit, decide who will answer FDA's questions, and how fast. Holds are where much of the time goes.
If you want a second view of that comparison, Complizen, which has a team in Malaysia, offers a free Gap Assessment that checks your device documents against what a 510(k) needs before you file. For the wider picture of selling in the US from outside it, see our international path.
Frequently asked questions
How does a Malaysian manufacturer get FDA approval?
Most devices from Malaysia need 510(k) clearance, not approval. That includes exam and surgeon's gloves, which are Class I but not exempt. You show that your device is substantially equivalent to a US predicate. Every device also needs FDA establishment registration, device listing and a US Agent before it is imported.
Do nitrile exam gloves need FDA clearance?
Yes. Nitrile exam gloves are Class I devices, but they are not exempt from a 510(k). For patient examination gloves, FDA's regulation exempts only finger cots. You also need to register your site, list the gloves and name a US Agent before you ship them to the US.
Does an MDA registration speed up FDA clearance?
No. FDA does not accept an MDA registration in place of a 510(k), and it does not shorten FDA's review. What can carry over is the evidence behind the registration, such as test reports to FDA-recognized standards and an ISO 13485 quality system. FDA judges that evidence on its own terms.
How many Malaysian medical devices has FDA cleared?
FDA cleared 58 510(k)s from applicants in Malaysia from January 2023 to September 2026, according to our count of FDA's public data. Fifty were gloves. Malaysia had more polymer exam glove clearances than any other country in that period, with 41 of 130.
How long does FDA clearance take for Malaysian gloves?
Malaysian polymer exam glove 510(k)s with a standard FDA review took a median of 153 days from receipt to clearance. Chinese applicants took 92 days and US applicants 97 for the same glove type. The few glove 510(k)s that used third-party review took a median of 31.5 days from FDA's receipt.
Can glove 510(k)s use third-party review?
Yes, for most glove types. FDA's classification database lists polymer and latex exam gloves, surgeon's gloves and specialty gloves as eligible. Opioid protection gloves are not. A third-party review has no FDA 510(k) fee, but you pay the review organization. Only 4 of 130 polymer exam glove clearances used it.
What is FDA Import Alert 80-04?
It is FDA's import alert for surgeon's and patient examination gloves. Firms on its list can have glove shipments detained without physical examination. FDA states that one violative sample is enough to recommend this. On October 13, 2026, the list included 42 manufacturers or shippers in Malaysia.
What AQL does FDA use for medical gloves?
FDA tests glove samples for leaks and visual defects, using a 1,000 ml water test. It treats a lot as adulterated if defects reach the reject number at a 1.5 AQL for surgeon's gloves or a 2.5 AQL for exam gloves. The sampling plans follow ISO 2859.
Are powdered gloves allowed in the US?
No. FDA bans powdered surgeon's gloves and powdered patient examination gloves. A non-powdered glove may contain only residual powder from manufacturing. Of the 24 exam glove summaries we read from 2025, 18 cited ASTM D6124, the test method for residual powder.
How much does a glove 510(k) cost in FY2027?
FDA's 510(k) fee for fiscal year 2027 is $28,653, or $7,163 for a qualifying small business. A third-party review has no FDA 510(k) fee, but the review organization charges its own. Annual establishment registration is $13,785. Testing and a US Agent are separate costs.
Can I use test reports from a Malaysian lab?
Yes. FDA accepts reports from Malaysian labs if they meet its expectations: the FDA-recognized standard version and a complete report in English. No Malaysian lab is in FDA's ASCA program yet, so plan for complete reports. Biocompatibility studies also need a statement on Good Laboratory Practice.
Do contract manufacturers in Malaysia need to register with FDA?
Yes. A site that makes a device for another company must register with FDA and list the device, even when the other company owns the design. In FDA's data, 147 Malaysian sites were registered as contract manufacturers, slightly more than the 143 registered as manufacturers of their own devices.
References
- openFDA. 510(k) API, decisions dated January 3, 2023 to September 27, 2026, and 510(k) summaries for product code LZA cleared in 2025, from FDA's 510(k) database. Accessed October 12, 2026.
- openFDA. Registration and Listing API, establishments in Malaysia. Accessed October 13, 2026.
- FDA. Medical Device User Fee Rates for Fiscal Year 2027. Federal Register, July 30, 2026.
- eCFR. Title 21: Part 807, Establishment Registration and Device Listing (§§ 807.20, 807.22, 807.40, 807.81, 807.92); § 800.20, Medical gloves: sample plans and adulteration; § 801.437, Labeling for devices that contain natural rubber; § 878.4460, Non-powdered surgeon's glove; § 880.6250, Non-powdered patient examination glove; § 880.9, Limitations of exemptions; §§ 895.102 and 895.103, Banned powdered gloves. Current as of October 2026.
- FDA. Electronic Submission Template for Medical Device 510(k) Submissions. Final guidance, October 2, 2023.
- FDA. Refuse to Accept Policy for 510(k)s. Final guidance, April 21, 2022.
- FDA. FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals. Final guidance, October 3, 2022.
- FDA. Import Alert 80-04: Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves. Published July 16, 2026. Accessed October 13, 2026.
- FDA. 510(k) Third Party Review Program. Content current as of November 20, 2024.
- FDA. ASCA-Accredited Testing Laboratories database. Accessed October 12, 2026.
- FDA. Product Classification database. Accessed October 13, 2026.
- FDA. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Final guidance, September 8, 2023.