Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling Claim of 50 Micrograms per DM2 of Glove
by Wear Safe (Malaysia) Sdn. Bhd.
510(k) K090066
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK090066 | Date15 May 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KGO
- Device Class
- Class I
- Regulation
- 21 CFR Part 878.4460
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent