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FDA 510(k)

Nitrile Blue Powder-free Examination Glove

K-Number: K211390 · 2021-08-28

ApplicantCardinal Health200, LLC
Decision Date2021-08-28
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Blue Powder-free Examination Glove is a medical device manufactured by Cardinal Health200, LLC. It received FDA 510(k) clearance on 2021-08-28 under approval number K211390. 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 Blue Powder-free Examination Glove?

Nitrile Blue Powder-free Examination Glove is a medical device that received FDA 510(k) clearance on 2021-08-28. It is manufactured by Cardinal Health200, LLC. The 510(k) number is K211390.

When was Nitrile Blue Powder-free Examination Glove approved by the FDA?

Nitrile Blue Powder-free Examination Glove received FDA 510(k) clearance on 2021-08-28, under approval number K211390.

What company makes Nitrile Blue Powder-free Examination Glove?

Nitrile Blue Powder-free Examination Glove is manufactured by Cardinal Health200, LLC.

What is the FDA product code for Nitrile Blue Powder-free Examination Glove?

The FDA product code for Nitrile Blue Powder-free Examination Glove is LZA.

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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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