510(k) K211810 ยท LZA Polymer Patient Examination Glove
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)
| Applicant | Pt. Shamrock Manufacturing Corpora, Kab. Deli Serdang, ID |
| Decision | Substantially Equivalent, May 23, 2022 |
| Received | Jun 11, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211810
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.