Amerisource Bergen 10907
by Bp Pharmaceuticals Laboratories Unlimited Company
Amerisource Bergen 10907 is a Class I device made by Bp Pharmaceuticals Laboratories Unlimited Company, cleared under FDA 510(k) K102444 on 22 Nov 2010 and listed in FDA GUDID since 4 Mar 2022 (UDI-DI 00368001109079), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00368001109079 | Date4 Mar 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102444 | Date22 Nov 2010 | StatusActive |
Official records
- AccessGUDID record 00368001109079
- FDA 510(k) database K102444
Across registries
- FDA 510(k) K102444 decided 22 Nov 2010 Active
- FDA GUDID UDI-DI 00368001109079 listed 4 Mar 2022 Listed
Timeline
- Cleared FDA 510(k) K102444
- Listed FDA GUDID 00368001109079
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Amerisource Bergen
- Generic name
- Vinyl examination/treatment glove, non-powdered
- Model / reference
- 10907
- Primary DI / UDI-DI
- 00368001109079
- 510(k) Number
- FDA product code
- LYZ
- GMDN term
- Vinyl examination/treatment glove, non-powdered
- Device class
- Class I
- Regulation number
- 880.6250
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Vinyl examination/treatment glove, non-powdered.
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