510(k) K001327 ยท LYY Latex Patient Examination Glove
POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)
| Applicant | Premier Pathway Sdn. Bhd., Sparks NV, US |
| Decision | Substantially Equivalent, May 23, 2000 |
| Received | Apr 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001327
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.