510(k) K013317 ยท LYY Latex Patient Examination Glove
TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
| Applicant | Tekmedic (M) Sdn Bhd, Alexandria VA, US |
| Decision | Substantially Equivalent, Dec 17, 2001 |
| Received | Oct 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013317
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.