Identity
- Trade Name
- Gammex FDA UDI
- Generic Name
- Polychloroprene surgical glove, non-powdered FDA UDI
- Device Name
- Gammex Non-Latex Sensitive Surgical 8.0 - 50 Pair/Box FDA UDI
- Model / Reference
- 71-AN77280 FDA UDI
- Description
- Gammex Non-Latex Sensitive Surgical 8.0 - 50 Pair/Box FDA UDI
Identifiers
- Catalog Number
- 71-AN77280 FDA UDI
- Primary DI / UDI-DI
- 10818634021516 FDA UDI
- FDA Product Code
- KGO FDA UDI
- GMDN Term
- Polychloroprene surgical glove, non-powdered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4460 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Category: Polychloroprene surgical glove, non-powdered
Gammex by Bosma Enterprises — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Bosma Enterprises
Sources (1)
- FDA UDI dac07bf5-7aed-41e7-a0ff-5af7d899c791 37 fields · synced Jun 8, 2026