FDA 510(k)

Powder Free Chloroprene Examination Glove Coloured (Blue, Green)

Número K: K213993 · 2022-08-05

Data da decisão2022-08-05

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Powder Free Chloroprene Examination Glove Coloured (Blue, Green) is the device name listed in this FDA 510(k) record. The listed applicant is Careglove Global Sdn. Bhd.. It received FDA 510(k) clearance on 2022-08-05 under 510(k) number K213993. 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 Powder Free Chloroprene Examination Glove Coloured (Blue, Green)?

Powder Free Chloroprene Examination Glove Coloured (Blue, Green) is a medical device that received FDA 510(k) clearance on 2022-08-05. The listed applicant is Careglove Global Sdn. Bhd.. The 510(k) number is K213993.

When did Powder Free Chloroprene Examination Glove Coloured (Blue, Green) receive FDA 510(k) clearance?

Powder Free Chloroprene Examination Glove Coloured (Blue, Green) received FDA 510(k) clearance on 2022-08-05, under 510(k) number K213993.

Who is the listed applicant for Powder Free Chloroprene Examination Glove Coloured (Blue, Green)?

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

What is the FDA product code for Powder Free Chloroprene Examination Glove Coloured (Blue, Green)?

The FDA product code for Powder Free Chloroprene Examination Glove Coloured (Blue, Green) is LZA.

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Fonte oficial

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