FDA 510(k)

Nitrile Patient Examination Powder Free Glove, Textured, Black

Número K: K161085 · 2018-07-05

Data da decisão2018-07-05

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Patient Examination Powder Free Glove, Textured, Black is the device name listed in this FDA 510(k) record. The listed applicant is Multisafe Sdn. Bhd.. It received FDA 510(k) clearance on 2018-07-05 under 510(k) number K161085. 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 Nitrile Patient Examination Powder Free Glove, Textured, Black?

Nitrile Patient Examination Powder Free Glove, Textured, Black is a medical device that received FDA 510(k) clearance on 2018-07-05. The listed applicant is Multisafe Sdn. Bhd.. The 510(k) number is K161085.

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

Nitrile Patient Examination Powder Free Glove, Textured, Black received FDA 510(k) clearance on 2018-07-05, under 510(k) number K161085.

Who is the listed applicant for Nitrile Patient Examination Powder Free Glove, Textured, Black?

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

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

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

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