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FDA 510(k)

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)

K-Number: K163126 · 2017-02-22

ApplicantBlue Sail Medical Co.,Ltd
Decision Date2017-02-22
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) is a medical device manufactured by Blue Sail Medical Co.,Ltd. It received FDA 510(k) clearance on 2017-02-22 under approval number K163126. 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 (Blue, White, Black, Violet Blue, Cobalt blue)?

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) is a medical device that received FDA 510(k) clearance on 2017-02-22. It is manufactured by Blue Sail Medical Co.,Ltd. The 510(k) number is K163126.

When was Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) approved by the FDA?

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) received FDA 510(k) clearance on 2017-02-22, under approval number K163126.

What company makes Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)?

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) is manufactured by Blue Sail Medical Co.,Ltd.

What is the FDA product code for Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)?

The FDA product code for Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) is LZA.

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Other Devices by Blue Sail Medical Co.,Ltd

K171782Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs

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

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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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