FDA 510(k)

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile

Número K: K221378 · 2022-09-30

RequerenteTec Gloves Industry (M) Sdn.Bhd.

Data da decisão2022-09-30

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Tec Gloves Industry (M) Sdn.Bhd.. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K221378. 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 Powder Free Blue Patient Examination Gloves, Non-Sterile?

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Tec Gloves Industry (M) Sdn.Bhd.. The 510(k) number is K221378.

When did Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile receive FDA 510(k) clearance?

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile received FDA 510(k) clearance on 2022-09-30, under 510(k) number K221378.

Who is the listed applicant for Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile?

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

What is the FDA product code for Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile?

The FDA product code for Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile is LZA.

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