510(k) K100694 ยท LYY Latex Patient Examination Glove
COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN
| Applicant | Tekmedic (M) Sdn Bhd, Jetty, Tanjung Kling, Malacca, MY |
| Decision | Substantially Equivalent, Jun 25, 2010 |
| Received | Mar 11, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100694
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Adenna Inc Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium,
Product Code PHM912, Lot No. 002-E1LF302-1, Manufacture date JUL 2011, Size Small
Product Cod Terminated |
LYY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.