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FDA 510(k)

Nitrile Vinyl Blend Powder Free Examination Gloves (Black)

K-Number: K213574 · 2022-07-12

ApplicantGrand Work Plastic Products Co., Ltd.
Decision Date2022-07-12
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is a medical device manufactured by Grand Work Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2022-07-12 under approval number K213574. 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 Nitrile Vinyl Blend Powder Free Examination Gloves (Black)?

Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is a medical device that received FDA 510(k) clearance on 2022-07-12. It is manufactured by Grand Work Plastic Products Co., Ltd.. The 510(k) number is K213574.

When was Nitrile Vinyl Blend Powder Free Examination Gloves (Black) approved by the FDA?

Nitrile Vinyl Blend Powder Free Examination Gloves (Black) received FDA 510(k) clearance on 2022-07-12, under approval number K213574.

What company makes Nitrile Vinyl Blend Powder Free Examination Gloves (Black)?

Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is manufactured by Grand Work Plastic Products Co., Ltd..

What is the FDA product code for Nitrile Vinyl Blend Powder Free Examination Gloves (Black)?

The FDA product code for Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is LZA.

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Other Devices by Grand Work Plastic Products Co., Ltd.

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Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd

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.

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