FDA 510(k)

Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile

Numéro K : K220428 · 2022-05-10

Date de décision2022-05-10

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is the device name listed in this FDA 510(k) record. The listed applicant is One Glove Industrial Sdn Bhd. It received FDA 510(k) clearance on 2022-05-10 under 510(k) number K220428. 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 Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile?

Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is a medical device that received FDA 510(k) clearance on 2022-05-10. The listed applicant is One Glove Industrial Sdn Bhd. The 510(k) number is K220428.

When did Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile receive FDA 510(k) clearance?

Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile received FDA 510(k) clearance on 2022-05-10, under 510(k) number K220428.

Who is the listed applicant for Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile?

The FDA 510(k) record lists One Glove Industrial Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile?

The FDA product code for Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is LZA.

Essais cliniques associés

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Autres dossiers indiquant One Glove Industrial Sdn Bhd en tant que demandeur

K220431Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile K220429Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile K220427White Nitrile Powder-Free Patient Examination Glove, Non Sterile

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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