510(k) K200019 ยท LZA Polymer Patient Examination Glove
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
| Applicant | Hartalega NGC Sdn. Bhd., Sepang, MY |
| Decision | Substantially Equivalent, Apr 6, 2020 |
| Received | Jan 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200019
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2026 | O&M HALYARD INC Halyard Purezero Ultraviolet Nitrile Exam Gloves
Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl) Open, Classified |
LZC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.