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FDA 510(k)

Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors

K-Number: K211455 · 2021-07-28

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 the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2021-07-28 under 510(k) 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. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K211455.

When did Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211455.

Who is the listed applicant for Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors?

The FDA 510(k) record lists Shen Wei USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Shen Wei USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 19 devices →

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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