FDA 510(k)

NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST

Número K: K162858 · 2017-07-24

Data da decisão2017-07-24

Código do produtoLZC

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST is the device name listed in this FDA 510(k) record. The listed applicant is Careplus (M) Sdn Bhd. It received FDA 510(k) clearance on 2017-07-24 under 510(k) number K162858. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST?

NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST is a medical device that received FDA 510(k) clearance on 2017-07-24. The listed applicant is Careplus (M) Sdn Bhd. The 510(k) number is K162858.

When did NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST receive FDA 510(k) clearance?

NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST received FDA 510(k) clearance on 2017-07-24, under 510(k) number K162858.

Who is the listed applicant for NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST?

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

What is the FDA product code for NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST?

The FDA product code for NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST is LZC.

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Outros registros que listam Careplus (M) Sdn Bhd como candidato(a)

K211621Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)K201857Powder Free Nitrile Examination Glove Black and Dual Color White-Blue K203705Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs K210656ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs K202765ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs

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