510(k) K012853 ยท LZA Polymer Patient Examination Glove
SMART GLOVE STERILE NITRILE EXAM GLOVE
| Applicant | Smart Glove Corp. Sdn Bhd, Klang Selangor, MY |
| Decision | Substantially Equivalent, Nov 16, 2001 |
| Received | Aug 24, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012853
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.