FDA 510(k)

Disposable Nitrile Examination Glove

Numéro K : K223281 · 2022-12-07

DemandeurAnhui Kindguard Medical Supplies Technology Co., Ltd.

Date de décision2022-12-07

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Nitrile Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Kindguard Medical Supplies Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-07 under 510(k) number K223281. 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 Disposable Nitrile Examination Glove?

Disposable Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Anhui Kindguard Medical Supplies Technology Co., Ltd.. The 510(k) number is K223281.

When did Disposable Nitrile Examination Glove receive FDA 510(k) clearance?

Disposable Nitrile Examination Glove received FDA 510(k) clearance on 2022-12-07, under 510(k) number K223281.

Who is the listed applicant for Disposable Nitrile Examination Glove?

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

What is the FDA product code for Disposable Nitrile Examination Glove?

The FDA product code for Disposable Nitrile Examination Glove is LZA.

Essais cliniques associés

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Autres dossiers indiquant Anhui Kindguard Medical Supplies Technology Co., Ltd. en tant que demandeur

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Dispositifs connexes (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.

Source officielle

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