FDA Registration for Medical Gloves
Gloves are the exception that proves the Class I rule: low class, but a full premarket and testing burden. Here's exactly what applies.
Key Takeaways
- Class I — but a 510(k) is required. Exam and surgeon's gloves both need premarket notification (unusual for Class I).
- Powdered medical gloves are banned (21 CFR 895, effective Jan 18, 2017) — non-powdered only.
- Surgeon's gloves are Class I, not Class II — a widely repeated error.
- Full device stack applies: registration + $11,423 fee, listing, U.S. Agent, Official Correspondent, QMSR, labeling.
- Glove-specific testing: leak/AQL, tensile, powder-free residual, biocompatibility, latex protein and labeling.
- Heavy import scrutiny — gloves are a top enforcement target at the border.
How FDA Classifies Medical Gloves
Both main glove types are Class I — the difference is which regulation and product code they fall under:
| Glove type | Regulation | Class | 510(k)? |
|---|---|---|---|
| Patient examination glove | 21 CFR 880.6250 | Class I | Required |
| Surgeon's glove | 21 CFR 878.4460 | Class I | Required |
| Finger cot | 21 CFR 880.6250 | Class I | Often exempt |
Why Gloves Need a 510(k) When Most Class I Devices Don't
Most Class I devices are exempt from premarket notification. Medical gloves are a deliberate exception. Because gloves are a primary barrier against the spread of infection, FDA determined that patient examination and surgeon's gloves — product codes including LYY, LYZ, OIG, OPC, OPH, LZC, and OPA — are of substantial importance in preventing impairment of health, and therefore require a 510(k).
Glove Testing & Standards
Barrier integrity
Leak/pinhole (watertightness) testing to an acceptable quality level (AQL) — the core barrier test.
Physical properties
Tensile strength, elongation, and dimensions, before and after aging.
Powder-free residual
Residual powder limits — powdered gloves are banned, so residual must stay within accepted limits.
Biocompatibility
Skin-contact biocompatibility appropriate to the material.
Latex & proteins
Natural rubber latex protein considerations and required latex labeling statements.
Consensus standards
ASTM specifications for rubber, nitrile, vinyl exam gloves and rubber surgical gloves, by material.
The Complete Compliance Stack for Gloves
| Requirement | What it involves | Applies? |
|---|---|---|
| 510(k) clearance | Premarket notification with predicate + test data | Required |
| Establishment registration | Annual, in FURLS; $11,423 FY2026 fee (Oct 1–Dec 31) | Required |
| Device listing | List each glove product and its activities | Required |
| U.S. Agent + Official Correspondent | Required for foreign establishments (807.40) | Required |
| QMSR (quality system) | 21 CFR 820 / ISO 13485:2016 — effective Feb 2, 2026 | Required |
| Labeling, latex & UDI | Device labeling (801), latex statements, UDI | Required |
| Non-powdered only | Powdered medical gloves are banned (895) | Mandatory |
How to Get Medical Gloves Compliant
Confirm glove type & product code
Exam or surgeon's glove, its product code, and — critically — that it's non-powdered.
Prepare & clear a 510(k)
Medical gloves need premarket notification: a valid predicate plus the required test data, cleared by FDA.
Meet glove testing & standards
Leak/AQL, tensile and elongation, powder-free residual, biocompatibility, and latex requirements to the applicable ASTM standards.
Register & appoint a U.S. Agent
Register in FURLS and pay the annual fee; foreign makers designate a U.S. Agent and an Official Correspondent.
List devices & finalize labeling
List each product and ensure labeling meets FDA requirements, including UDI and natural rubber latex statements.
Maintain QMSR & renew annually
Operate under QMSR, keep listings current, renew each fiscal year, and manage import compliance to avoid detention.
Register Your Medical Gloves the Right Way
FDA Registration Assistance handles establishment registration and device listing, serves as your U.S. Agent and Official Correspondent, supports the 510(k) and the testing it requires, and aligns QMSR and labeling — so your medical device gloves reach the U.S. market without avoidable delays.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Trusted by device makers in 135+ countries, with 15+ years of FDA experience.
Frequently Asked Questions — Medical Gloves
1. Are medical gloves regulated by the FDA?
Yes — patient examination and surgeon's gloves are medical devices, because they guard against contamination and the spread of pathogens. They fall under FDA device rules: registration, listing, quality systems, premarket notification, and labeling.
2. What class are medical gloves?
Both patient exam gloves (880.6250) and surgeon's gloves (878.4460) are Class I. The common belief that surgeon's gloves are Class II is incorrect. What's unusual is that they still require a 510(k).
3. Do medical gloves require a 510(k)?
Yes — the key point. Though most Class I devices are exempt, FDA determined that exam and surgeon's gloves (product codes including LYY, LYZ, OIG, OPC, OPH, LZC, OPA) require a 510(k) due to their infection-control role. Registration and listing alone aren't enough.
4. Are powdered medical gloves allowed?
No. Powdered surgeon's gloves, powdered patient exam gloves, and absorbable powder for lubricating a surgeon's glove are banned (21 CFR 895), effective Jan 18, 2017. Only non-powdered medical gloves may be sold; powdered radiographic protection gloves were the narrow exception.
5. Why were powdered gloves banned?
FDA found they present an unreasonable, substantial risk — airway and wound inflammation and post-surgical adhesions from the powder — that labeling couldn't fix, so they were added to the banned-device list.
6. What testing do medical gloves need?
Typically leak/pinhole (watertightness) to an AQL, tensile strength and elongation, dimensions, powder-free residual limits, and biocompatibility, plus latex protein and labeling considerations for natural rubber latex. Specific standards depend on material and glove type.
7. Which standards apply?
FDA recognizes ASTM specifications for rubber, nitrile, and vinyl examination gloves and rubber surgical gloves, among others. Your 510(k) generally shows conformance to the standards for your glove's material and use.
8. Do foreign glove makers need a U.S. Agent?
Yes — a foreign establishment must designate a U.S. Agent (and has an Official Correspondent for registration/listing communications). The U.S. Agent is FDA's domestic contact for the facility.
9. What's the establishment registration fee?
The standard annual device establishment fee — $11,423 for FY2026, reset each fiscal year, paid Oct 1–Dec 31. There's no separate FDA listing fee.
10. Does registration mean my gloves are FDA approved?
No. Registration and listing identify your facility and products; a cleared 510(k) is a marketing authorization, not "approval." FDA doesn't "approve" gloves — "FDA cleared" is the accurate term where a 510(k) applies.
11. Does QMSR apply to gloves?
Yes — glove makers operate under QMSR (updated 21 CFR 820, incorporating ISO 13485:2016, effective Feb 2, 2026). Quality control over materials, testing, and release is central for gloves.
12. How are latex gloves labeled?
Natural rubber latex gloves must state they contain natural rubber latex, which may cause allergic reactions, and can't be labeled "hypoallergenic." Any protein-level claims must be supported.
13. Do medical gloves need a UDI?
Generally yes — UDI applies to medical gloves, so labels and packaging typically must carry one. Confirm requirements and any exceptions for your product and packaging levels.
14. Why do gloves face extra import scrutiny?
Gloves are a very high-volume import category with significant enforcement against substandard, reprocessed, or misrepresented product. Shipments from establishments that aren't properly registered, listed, cleared, or standards-compliant can be detained or refused.
15. Are surgeon's and exam gloves treated the same?
Similar but distinct: both are Class I and both need a 510(k), but under different regulations (surgeon's 878.4460, exam 880.6250) with different codes and some different performance expectations. Each is registered, listed, and cleared appropriately.
16. Can I sell gloves online without compliance?
No. Selling medical gloves into the U.S., including online, without proper registration, listing, a cleared 510(k), and compliant labeling can lead to import refusal and enforcement — and marketplaces increasingly require proof of compliance.
17. How does FDA Registration Assistance help?
It handles registration and listing, serves as U.S. Agent and Official Correspondent, supports the 510(k) and its testing, aligns QMSR and labeling (latex, UDI), and helps keep imports moving — for device makers in 135+ countries.
18. How do I get started?
Contact FDA Registration Assistance at info@fdaregistrationassistance.com or call +1 (928) 275-8333 with your glove type, material, and intended use for a clear plan.
