510(k) K010438 ยท KGO Surgeon'S Gloves
MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)
| Applicant | Terang Nusa Sdn Bhd, Kota Bharu, MY |
| Decision | Substantially Equivalent, May 1, 2001 |
| Received | Feb 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010438
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.