510(k) K011613 ยท LZA Polymer Patient Examination Glove
POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE
| Applicant | Shield Gloves Manufacturer (M) Sdn Bhd, Sparks NV, US |
| Decision | Substantially Equivalent, Sep 17, 2001 |
| Received | May 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011613
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.