Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K241909)
Description
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid by O&M Halyard, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
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Predicate lineage for K241909
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K241909) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213937 | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-... | O&M Halyard, Inc. | 2022 |
| K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for ... | O&M Halyard, Inc. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low D... | O&M Halyard, Inc. | 2025 |
Trace the full predicate network for K241909
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.