The short answer
Gloves, masks and gowns are medical devices in the U.S. when they are sold for medical use — and several common items need 510(k) clearance even though they look simple. The same product sold for general use is not a medical device.
What exporters should watch for
🧤 Examination and surgical gloves
Patient examination gloves are Class I devices that still need 510(k) clearance; surgeon’s gloves need 510(k) too. The factory registers with FDA, lists the gloves, names a U.S. Agent and pays FDA’s annual fee.
😷 Surgical masks and respirators
Surgical masks are Class II devices that generally need 510(k). Respirators such as N95s also involve NIOSH approval. Masks sold only for general, non-medical use are not medical devices.
🥼 Gowns and drapes
Surgical gowns and drapes are medical devices with their own classification; some need 510(k). Non-surgical isolation gowns may be exempt but still need registration and listing.
📋 Quality system
Since February 2, 2026, FDA’s device quality rule is the QMSR, which incorporates ISO 13485. FDA inspects foreign glove and mask factories.
Common reasons shipments are stopped
- Medical gloves or masks without 510(k)
- Devices not listed or factory not registered
- Labels claiming medical use on general-use products
- Quality system findings at inspection
- Missing U.S. Agent
🏢 No U.S. company to act as FSVP importer? Orionex can be your U.S. FSVP importer (FSVP agent) for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
What you need to register — and what it costs
| Product type | FDA requirement | Orionex price |
|---|---|---|
| Food, beverages, supplements | Food facility registration + U.S. Agent, renewed every 2 years; Prior Notice for each shipment | $300/year or $450 for 2 years |
| Cosmetics | MoCRA facility registration (every 2 years) + product listing + U.S. Agent | $300/year or $450 for 2 years; listing $150/product |
| Medical devices | Establishment registration (yearly, FDA fee paid separately) + device listing; 510(k) for many Class II devices | $550/year; listing $50/device |
| Drugs (incl. OTC) | Drug establishment registration (yearly) + NDC labeler code + drug listing | $550/year; listing $350/product |
Every Orionex registration includes the U.S. Agent service, D-U-N-S number set-up where needed and a Certificate of Registration. All prices →
Tell us your product — we’ll confirm what FDA requires, in writing, by email.
Frequently asked questions
Do examination gloves need FDA 510(k)?
Yes. Patient examination gloves are Class I medical devices, but unlike most Class I devices they require 510(k) clearance before sale. The manufacturer must also register with FDA, list the gloves, name a U.S. Agent and pay the annual establishment fee.
Are non-medical masks regulated by FDA?
Masks sold only for general, non-medical use (for example dust or fashion masks) are not medical devices. If the label or marketing claims protection against infection or medical use, the mask becomes a medical device with FDA requirements.
Sources
- eCFR — 21 CFR 880.6250, Non-powdered patient examination glove
- FDA — Quality Management System Regulation (QMSR)
- FDA — Import Alerts by Publish Date
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.