510(k) K220825 ยท LZA Polymer Patient Examination Glove
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
| Applicant | American Nitrile Operations, LLC, Grove City OH, US |
| Decision | Substantially Equivalent, Jul 8, 2022 |
| Received | Mar 21, 2022 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K220825
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | American Nitrile Operations Llc Brand Name: Performance Pro
Product Name: Performance Pro
Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604
Product Description: Blue Nitrile Patient examination gloves Open, Classified |
LZA | None listed |
| Sep 25, 2026 | American Nitrile Operations Llc Brand Name: Opportunity Flex
Product Name: Opportunity Flex
Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904
Product Description: Blue Nitrile Patient examination gloves Open, Classified |
LZA | None listed |
| Sep 25, 2026 | American Nitrile Operations Llc Brand Name: Opportunity Pro
Product Name: Opportunity Pro
Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804
Product Description: Blue Nitrile patient examination glove Open, Classified |
LZA | None listed |
| Jul 9, 2024 | SVS LLC Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder Open, Classified |
LZC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.