510(k) K101630 ยท LZA Polymer Patient Examination Glove
POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE
| Applicant | Pt. Smartglove Indonesia, Morawa,Deli Serdang,Sumatera U, ID |
| Decision | Substantially Equivalent, Sep 7, 2010 |
| Received | Jun 10, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101630
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.