Identity
- Trade Name
- Layer4 FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Layer4 RapidDon Nitrile Exam Gloves Small 250 per Box FDA UDI
- Model / Reference
- 3925-2200 FDA UDI
- Description
- Layer4 RapidDon Nitrile Exam Gloves Small 250 per Box FDA UDI
Identifiers
- Catalog Number
- 3925-2200 FDA UDI
- Primary DI / UDI-DI
- 00850064227123 FDA UDI
- 510(k) Number
- K102790 FDA UDI
- FDA Product Code
- LZC FDA UDI
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Layer4 by Usa Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Usa Scientific, Inc.
Sources (1)
- FDA UDI eec19a4f-6a5a-4401-ae7d-f9401de1af7f 37 fields · synced May 30, 2026