510(k) K191869 ยท KGO Surgeon'S Gloves
Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
| Applicant | Molnlycke Health Care Us, LLC, Norcross GA, US |
| Decision | Substantially Equivalent, Mar 13, 2020 |
| Received | Jul 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191869
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.