Identity
- Trade Name
- APFGXL FDA UDI
- Generic Name
- Radiation-shielding procedure preparation glove/mitten FDA UDI
- Device Name
- radiographic protective glove size XL FDA UDI
- Model / Reference
- Size XL FDA UDI
- Description
- radiographic protective glove size XL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010574553 FDA UDI
- FDA Product Code
- IWP FDA UDI
- GMDN Term
- Radiation-shielding procedure preparation glove/mitten FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.6500 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
Yes
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-powderedRadiation-shielding procedure preparation glove/mitten
Apfgxl by F & L Medical Products Co. — 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
- F & L Medical Products Co.
Sources (1)
- FDA UDI 059afc26-82a8-4a50-a6db-9a59ca17a316 33 fields · synced Jun 1, 2026