FDA 510(k)

Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl

Número K: K192954 · 2020-06-19

RequerenteComfort Rubber Gloves Industries Sdn. Bhd.

Data da decisão2020-06-19

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl is the device name listed in this FDA 510(k) record. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2020-06-19 under 510(k) number K192954. 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 Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl?

Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl is a medical device that received FDA 510(k) clearance on 2020-06-19. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. The 510(k) number is K192954.

When did Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl receive FDA 510(k) clearance?

Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl received FDA 510(k) clearance on 2020-06-19, under 510(k) number K192954.

Who is the listed applicant for Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl?

The FDA 510(k) record lists Comfort Rubber Gloves Industries Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl?

The FDA product code for Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl is LZA.

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Outros registros que listam Comfort Rubber Gloves Industries Sdn. Bhd. como candidato(a)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein K240269Nitrile Powder Free Examination Gloves Biodegradable (Green)K241528Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential K200181Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K190080Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)K180476Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

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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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