510(k) K000217 ยท LYY Latex Patient Examination Glove
ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W
| Applicant | Shield Gloves Manufacturer (M) Sdn Bhd, Sparks NV, US |
| Decision | Substantially Equivalent, Feb 18, 2000 |
| Received | Jan 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000217
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.