FDA 510(k)

Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles

Numéro K : K243172 · 2025-06-18

Date de décision2025-06-18

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K243172. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles?

Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K243172.

When did Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles receive FDA 510(k) clearance?

Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles received FDA 510(k) clearance on 2025-06-18, under 510(k) number K243172.

Who is the listed applicant for Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles?

The FDA 510(k) record lists O&M Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles?

The FDA product code for Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles is LZA.

Essais cliniques associés

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Autres dossiers indiquant O&M Halyard, Inc. en tant que demandeur

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Source officielle

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