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FDA 510(k)

Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves

K-Number: K220825 · 2022-07-08

ApplicantAmerican Nitrile Operations, LLC
Decision Date2022-07-08
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves is a medical device manufactured by American Nitrile Operations, LLC. It received FDA 510(k) clearance on 2022-07-08 under approval number K220825. 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 Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves?

Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves is a medical device that received FDA 510(k) clearance on 2022-07-08. It is manufactured by American Nitrile Operations, LLC. The 510(k) number is K220825.

When was Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves approved by the FDA?

Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves received FDA 510(k) clearance on 2022-07-08, under approval number K220825.

What company makes Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves?

Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves is manufactured by American Nitrile Operations, LLC.

What is the FDA product code for Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves?

The FDA product code for Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves is LZA.

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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