PremierPro 4041
PremierPro 4041 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 00854344002493), active as of 22 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 | Number00854344002493 | Date24 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK100326 | Date24 Mar 2010 | StatusActive |
Official records
- AccessGUDID record 00854344002493
- FDA 510(k) database K100326
Across registries
- FDA 510(k) K100326 decided 24 Mar 2010 Active
- FDA GUDID UDI-DI 00854344002493 listed 24 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K100326
- Listed FDA GUDID 00854344002493
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- Withdrawn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
- 4041
- Primary DI / UDI-DI
- 00854344002493
- 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
Other devices filed under FDA product code LYZ (Vinyl Patient Examination Glove).
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- NitriTec Vinyl Glove Powder Free Blue by Zhonghong Pulin Medical Products Co., Ltd.
- VINYL EXAMINATION GLOVES by Tong Shiung Plastics Industry
- SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE by Ever Light Plastic Products Co., Ltd.
- POWDERED VINYL EXAM GLOVES, WHITE by Heyuan Hongli Industries, Inc.