510(k) K994354 ยท LYY Latex Patient Examination Glove
POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
| Applicant | Flexitech Sdn. Bhd., Klang, Selangor, MY |
| Decision | Substantially Equivalent, Jan 31, 2000 |
| Received | Dec 23, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994354
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.