510(k) K000295 ยท KGO Surgeon'S Gloves
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
| Applicant | Ansell Perry, Massillon OH, US |
| Decision | Substantially Equivalent, Feb 16, 2000 |
| Received | Jan 31, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000295
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2010 | Ansell Healthcare Products LLC ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R, CE 0086, EC REP Ansell (UK) Ltd., Tamworth, Staffordshire, B79 7UL UK, Ansell Lanka (pvt) Ltd., Biyagama Export Terminated |
KGO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.