510(k) K130450 ยท KGO Surgeon'S Gloves
SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE
| Applicant | Purna Bina Sdn Bhd, Kluang, Johor, MY |
| Decision | Substantially Equivalent, Sep 30, 2014 |
| Received | Feb 22, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130450
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.