510(k) K001280 ยท LYY Latex Patient Examination Glove
COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES
| Applicant | Wrp Asia Pacific Sdn. Bhd., Salak Tinggi, Sepang Selangor, MY |
| Decision | Substantially Equivalent, May 15, 2000 |
| Received | Apr 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001280
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.