510(k) K160781 ยท KGO Surgeon'S Gloves
Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
| Applicant | Semperit Investments Asia Pte , Ltd., Singapore, SG |
| Decision | Substantially Equivalent, May 2, 2017 |
| Received | Mar 22, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K160781
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.