510(k) K973815 ยท LYY Latex Patient Examination Glove
HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR)
| Applicant | Sri Johani Sdn. Bhd., Selangor, MY |
| Decision | Substantially Equivalent, Nov 21, 1997 |
| Received | Oct 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973815
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.