510(k) K011066 ยท KGO Surgeon'S Gloves
STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
| Applicant | Smart Glove Corp. Sdn Bhd, Klang Selangor, MY |
| Decision | Substantially Equivalent, Sep 11, 2001 |
| Received | Apr 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011066
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.