510(k) K050527 ยท LYY Latex Patient Examination Glove
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL
| Applicant | Spi Gloves Sdn. Bhd., Ipoh 30450, MY |
| Decision | Substantially Equivalent, Mar 18, 2005 |
| Received | Mar 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050527
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.