FDA 510(k)

EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs

Número K: K161187 · 2016-09-09

Data da decisão2016-09-09

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Eco Medi Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K161187. 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 EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs?

EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Eco Medi Glove Sdn. Bhd.. The 510(k) number is K161187.

When did EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs receive FDA 510(k) clearance?

EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs received FDA 510(k) clearance on 2016-09-09, under 510(k) number K161187.

Who is the listed applicant for EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs?

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

What is the FDA product code for EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs?

The FDA product code for EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs is LZA.

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Outros registros que listam Eco Medi Glove Sdn. Bhd. como candidato(a)

K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid K232764Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K233405Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim K220943Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim K202401Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein K193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims

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Dispositivos Relacionados (Código: LZA)

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