PremierPro 4032
PremierPro 4032 is a Class I device made by Prestige Ameritech, cleared under FDA 510(k) K100326 on 24 Mar 2010 and listed in FDA GUDID since 24 Jun 2020 (UDI-DI 00818566012630), 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 | Number00818566012630 | Date24 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK100326 | Date24 Mar 2010 | StatusActive |
Official records
- AccessGUDID record 00818566012630
- FDA 510(k) database K100326
Across registries
- FDA 510(k) K100326 decided 24 Mar 2010 Active
- FDA GUDID UDI-DI 00818566012630 listed 24 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K100326
- Listed FDA GUDID 00818566012630
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PremierPro
- Generic name
- Vinyl examination/treatment glove, non-powdered
- Model / Ref / Catalog
- 4032
- Primary DI / UDI-DI
- 00818566012630
- 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.