Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)
510(k) K081027
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081027 | Date30 Jun 2008 | StatusActive |
Recalls
-
- Terminated Z-0758-2017
Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LZA
- Device Class
- Class I
- Regulation
- 21 CFR Part 880.6250
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent