510(k) K003545 ยท LYY Latex Patient Examination Glove
NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE
| Applicant | Terang Nusa Sdn Bhd, Kota Bharu, MY |
| Decision | Substantially Equivalent, Dec 21, 2000 |
| Received | Nov 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003545
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.