FDA 510(k)

Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)

K-Nummer: K222498 · 2022-10-26

AntragstellerHumanwell Healthcare Group Medical Supplies Co., Ltd.

Entscheidungsdatum2022-10-26

ProduktcodeLZA

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) is the device name listed in this FDA 510(k) record. The listed applicant is Humanwell Healthcare Group Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K222498. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)?

Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Humanwell Healthcare Group Medical Supplies Co., Ltd.. The 510(k) number is K222498.

When did Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) receive FDA 510(k) clearance?

Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) received FDA 510(k) clearance on 2022-10-26, under 510(k) number K222498.

Who is the listed applicant for Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)?

The FDA 510(k) record lists Humanwell Healthcare Group Medical Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)?

The FDA product code for Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) is LZA.

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Verwandte Geräte (Code: LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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