510(k) K010054 ยท LYY Latex Patient Examination Glove
GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
| Applicant | Guthrie Medicare Products (Melaka) Sdn Bhd, Great Neck NY, US |
| Decision | Substantially Equivalent, Jan 26, 2001 |
| Received | Jan 8, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010054
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.