FDA 510(k)

Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein

Número K: K190632 · 2019-10-24

Data da decisão2019-10-24

Código do produtoKGO

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein is the device name listed in this FDA 510(k) record. The listed applicant is Lenora Glove Pvt , Ltd.. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K190632. 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 Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein?

Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Lenora Glove Pvt , Ltd.. The 510(k) number is K190632.

When did Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein receive FDA 510(k) clearance?

Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein received FDA 510(k) clearance on 2019-10-24, under 510(k) number K190632.

Who is the listed applicant for Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein?

The FDA 510(k) record lists Lenora Glove Pvt , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein?

The FDA product code for Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein is KGO.

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