FDA 510(k)

Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile

Número K: K220429 · 2022-05-13

Data da decisão2022-05-13

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Violet 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 2022-05-13 under 510(k) number K220429. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile?

Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is One Glove Industrial Sdn Bhd. The 510(k) number is K220429.

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

Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2022-05-13, under 510(k) number K220429.

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

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

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Outros registros que listam One Glove Industrial Sdn Bhd como candidato(a)

K220431Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile K220427White Nitrile Powder-Free Patient Examination Glove, Non Sterile K220428Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile

Dispositivos Relacionados (Código: 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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