510(k) K091652 ยท LZA Polymer Patient Examination Glove
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
| Applicant | Hartalega Sdn Bhd, Bestari Jaya, MY |
| Decision | Substantially Equivalent, Sep 4, 2009 |
| Received | Jun 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091652
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.