510(k) K193573 ยท KGO Surgeon'S Gloves
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
| Applicant | Molnlycke Health Care Us, LLC, Norcross GA, US |
| Decision | Substantially Equivalent, Apr 10, 2020 |
| Received | Dec 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193573
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.