FDA 510(k)

Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)

Número K: K212408 · 2022-05-18

Data da decisão2022-05-18

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Maja Agung Latexindo. It received FDA 510(k) clearance on 2022-05-18 under 510(k) number K212408. 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 Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)?

Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) is a medical device that received FDA 510(k) clearance on 2022-05-18. The listed applicant is Pt. Maja Agung Latexindo. The 510(k) number is K212408.

When did Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) received FDA 510(k) clearance on 2022-05-18, under 510(k) number K212408.

Who is the listed applicant for Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)?

The FDA 510(k) record lists Pt. Maja Agung Latexindo as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)?

The FDA product code for Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) is LZA.

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Outros registros que listam Pt. Maja Agung Latexindo como candidato(a)

K161099Powder Free Nitrile Examination Gloves, Black

Dispositivos Relacionados (Código: LZA)

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