510(k) K011407 ยท LYY Latex Patient Examination Glove
LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO
| Applicant | Sempermed USA, Inc., Palm Harbor FL, US |
| Decision | Substantially Equivalent, Sep 11, 2001 |
| Received | Apr 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011407
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.