510(k) K982957 ยท KGO Surgeon'S Gloves
SENSIFLEX POWDERFREE SURGEON'S GLOVE
| Applicant | Terang Nusa Sdn Bhd, Kota Bharu, Kelantan, MY |
| Decision | Substantially Equivalent, Jan 13, 1999 |
| Received | Aug 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982957
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2006 | Terang Nusa Sdn Bhd Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes per carton; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malayia Terminated |
KGO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.