510(k) K172942 · KGO Surgeon'S Gloves
Pristeen (Latex Surgeons Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein
| Applicant | Beta Healthcare Products Pvt., Ltd., Kochi, IN |
| Decision | Substantially Equivalent, Jan 8, 2018 |
| Received | Sep 26, 2017 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K172942
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.