Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with Protein Content Labeling Claim (50 Micrograms or Le)
by Ansell Perry
510(k) K983489
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 | NumberK983489 | Date14 Dec 1998 | 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- Withdrawn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