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FDA 510(k)

Nitrile examination gloves

K-Number: K211927 · 2021-10-12

ApplicantFitone Latex Products Co., Ltd. Guangdong
Decision Date2021-10-12
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile examination gloves is a medical device manufactured by Fitone Latex Products Co., Ltd. Guangdong. It received FDA 510(k) clearance on 2021-10-12 under approval number K211927. 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 examination gloves?

Nitrile examination gloves is a medical device that received FDA 510(k) clearance on 2021-10-12. It is manufactured by Fitone Latex Products Co., Ltd. Guangdong. The 510(k) number is K211927.

When was Nitrile examination gloves approved by the FDA?

Nitrile examination gloves received FDA 510(k) clearance on 2021-10-12, under approval number K211927.

What company makes Nitrile examination gloves?

Nitrile examination gloves is manufactured by Fitone Latex Products Co., Ltd. Guangdong.

What is the FDA product code for Nitrile examination gloves?

The FDA product code for Nitrile examination gloves is LZA.

Related Clinical Trials

NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING

Other Devices by Fitone Latex Products Co., Ltd. Guangdong

K221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs K222693Single-use medical latex examination gloves (LG100) K231446Single-Use Latex Sterile Surgical Gloves (SG100)

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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