510(k) K051563 ยท KGO Surgeon'S Gloves
NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED
| Applicant | Terang Nusa Sdn Bhd, Kota Bharu, Kelantan, MY |
| Decision | Substantially Equivalent, Jun 20, 2005 |
| Received | Jun 13, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051563
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2007 | Terang Nusa Sdn Bhd Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Manufactured for Medline Industries, Inc Terminated |
KGO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.