510(k) K972621 ยท KGO Surgeon'S Gloves
PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
| Applicant | Wembley Rubber Products (M) Sdn Bhd, Salak Tinggi, Sepang Selangor, MY |
| Decision | Substantially Equivalent, Oct 24, 1997 |
| Received | Jul 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972621
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.