510(k) K010439 ยท KGO Surgeon'S Gloves
MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
| Applicant | Terang Nusa Sdn Bhd, Kota Bharu, MY |
| Decision | Substantially Equivalent, May 1, 2001 |
| Received | Feb 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010439
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.