510(k) K012135 ยท KGO Surgeon'S Gloves
POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
| Applicant | Wrp Asia Pacific Sdn. Bhd., Salak Tinggi, Sepang Selangor, MY |
| Decision | Substantially Equivalent, Aug 1, 2001 |
| Received | Jul 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012135
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.