510(k) K000421 ยท KGO Surgeon'S Gloves
BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE
| Applicant | Ssl Americas, Inc. (Regent Medical), Norcross GA, US |
| Decision | Substantially Equivalent, Aug 14, 2000 |
| Received | Feb 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000421
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2002 | SSL Americas Inc. Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastomer, Sterile/R, REGENT, Made in Malaysia, Regent Medical, Norcross, GA USA 30092, Terminated |
KGO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.