510(k) K081970 ยท LZA Polymer Patient Examination Glove
BIOCLEAN CHEMO SHIELD
| Applicant | Nitritex (M) Sdn. Bhd., Kuala Langat, Selangor De, MY |
| Decision | Substantially Equivalent, Mar 11, 2009 |
| Received | Jul 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081970
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.