FDA 510(k)

Sterile Nitrile Surgical Gloves Powder Free

Número K: K222350 · 2023-04-13

RequerenteJr Engineering & Medical Technologies (M) Sdn. Bhd.

Data da decisão2023-04-13

Código do produtoKGO

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Nitrile Surgical Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K222350. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterile Nitrile Surgical Gloves Powder Free?

Sterile Nitrile Surgical Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K222350.

When did Sterile Nitrile Surgical Gloves Powder Free receive FDA 510(k) clearance?

Sterile Nitrile Surgical Gloves Powder Free received FDA 510(k) clearance on 2023-04-13, under 510(k) number K222350.

Who is the listed applicant for Sterile Nitrile Surgical Gloves Powder Free?

The FDA 510(k) record lists Jr Engineering & Medical Technologies (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Nitrile Surgical Gloves Powder Free?

The FDA product code for Sterile Nitrile Surgical Gloves Powder Free is KGO.

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Outros registros que listam Jr Engineering & Medical Technologies (M) Sdn. Bhd. como candidato(a)

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Fonte oficial

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