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FDA 510(k)

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

K-Number: K190632 · 2019-10-24

ApplicantLenora Glove Pvt , Ltd.
Decision Date2019-10-24
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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 manufactured by Lenora Glove Pvt , Ltd.. It received FDA 510(k) clearance on 2019-10-24 under approval number K190632. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Lenora Glove Pvt , Ltd.. The 510(k) number is K190632.

When was Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein approved by the FDA?

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 approval number K190632.

What company makes 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 manufactured by Lenora Glove Pvt , Ltd..

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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