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FDA 510(k)

Chemotherapy Gloves

K-Number: K230847 · 2023-09-29

Applicant3A Glove Sdn. Bhd.
Decision Date2023-09-29
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Chemotherapy Gloves is a medical device manufactured by 3A Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2023-09-29 under approval number K230847. 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 Chemotherapy Gloves?

Chemotherapy Gloves is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by 3A Glove Sdn. Bhd.. The 510(k) number is K230847.

When was Chemotherapy Gloves approved by the FDA?

Chemotherapy Gloves received FDA 510(k) clearance on 2023-09-29, under approval number K230847.

What company makes Chemotherapy Gloves?

Chemotherapy Gloves is manufactured by 3A Glove Sdn. Bhd..

What is the FDA product code for Chemotherapy Gloves?

The FDA product code for Chemotherapy Gloves is LZA.

Related Clinical Trials

NCT06823440 Prevention of CIPN Using Compressive Therapy RECRUITING

Other Devices by 3A Glove Sdn. Bhd.

K230777Patient Examination Gloves

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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