510(k) K111139 ยท KGO Surgeon'S Gloves
DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U
| Applicant | Ansell Healthcare Products, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Sep 2, 2011 |
| Received | Apr 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111139
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2023 | Ansell Healthcare Products LLC GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 Open, Classified |
KGO | None listed |
| Oct 11, 2023 | Ansell Healthcare Products LLC NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290 Open, Classified |
KGO | None listed |
| Feb 19, 2022 | Ansell Healthcare Products LLC Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 Open, Classified |
KGO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.