510(k) K010961 ยท LYY Latex Patient Examination Glove
X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
| Applicant | Ansell Healthcare Products, Inc., Massillon OH, US |
| Decision | Substantially Equivalent, May 31, 2001 |
| Received | Mar 30, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010961
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.