FDA 510(k)

Powder Free Polychloroprene Examination Glove Green

Número K: K153510 · 2016-03-21

Data da decisão2016-03-21

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Powder Free Polychloroprene Examination Glove Green is the device name listed in this FDA 510(k) record. The listed applicant is Terang Nusa Sdn Bhd. It received FDA 510(k) clearance on 2016-03-21 under 510(k) number K153510. 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 Polychloroprene Examination Glove Green?

Powder Free Polychloroprene Examination Glove Green is a medical device that received FDA 510(k) clearance on 2016-03-21. The listed applicant is Terang Nusa Sdn Bhd. The 510(k) number is K153510.

When did Powder Free Polychloroprene Examination Glove Green receive FDA 510(k) clearance?

Powder Free Polychloroprene Examination Glove Green received FDA 510(k) clearance on 2016-03-21, under 510(k) number K153510.

Who is the listed applicant for Powder Free Polychloroprene Examination Glove Green?

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

What is the FDA product code for Powder Free Polychloroprene Examination Glove Green?

The FDA product code for Powder Free Polychloroprene Examination Glove Green is LZA.

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Outros registros que listam Terang Nusa Sdn Bhd como candidato(a)

K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink

Dispositivos Relacionados (Código: LZA)

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