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FDA 510(k)

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)

K-Number: K212532 · 2021-11-11

ApplicantCrdlight Optoelectronic Technology Co., Ltd.
Decision Date2021-11-11
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) is a medical device manufactured by Crdlight Optoelectronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-11 under approval number K212532. 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 Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)?

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-11-11. It is manufactured by Crdlight Optoelectronic Technology Co., Ltd.. The 510(k) number is K212532.

When was Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) approved by the FDA?

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) received FDA 510(k) clearance on 2021-11-11, under approval number K212532.

What company makes Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)?

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) is manufactured by Crdlight Optoelectronic Technology Co., Ltd..

What is the FDA product code for Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)?

The FDA product code for Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) 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

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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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