Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors
K-Number: K211455 · 2021-07-28
ApplicantShen Wei USA, Inc.
Decision Date2021-07-28
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors is a medical device manufactured by Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2021-07-28 under approval number K211455. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors?
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors is a medical device that received FDA 510(k) clearance on 2021-07-28. It is manufactured by Shen Wei USA, Inc.. The 510(k) number is K211455.
When was Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors approved by the FDA?
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors received FDA 510(k) clearance on 2021-07-28, under approval number K211455.
What company makes Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors?
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors is manufactured by Shen Wei USA, Inc..
What is the FDA product code for Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors?
The FDA product code for Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors is LZA.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.