510(k) K161008 ยท KGO Surgeon'S Gloves
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
| Applicant | Hartalega Sdn Bhd, Bandar Sri Damansara, MY |
| Decision | Substantially Equivalent, Jul 28, 2016 |
| Received | Apr 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161008
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.