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FDA 510(k)

Medical Examination Gloves

K-Number: K212078 · 2021-10-08

ApplicantGuangdong Gymda Medical Technology Co.,Ltd
Decision Date2021-10-08
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medical Examination Gloves is a medical device manufactured by Guangdong Gymda Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2021-10-08 under approval number K212078. 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 Medical Examination Gloves?

Medical Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-10-08. It is manufactured by Guangdong Gymda Medical Technology Co.,Ltd. The 510(k) number is K212078.

When was Medical Examination Gloves approved by the FDA?

Medical Examination Gloves received FDA 510(k) clearance on 2021-10-08, under approval number K212078.

What company makes Medical Examination Gloves?

Medical Examination Gloves is manufactured by Guangdong Gymda Medical Technology Co.,Ltd.

What is the FDA product code for Medical Examination Gloves?

The FDA product code for Medical Examination Gloves is LZA.

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Related PubMed Literature

PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025)

Other Devices by Guangdong Gymda Medical Technology Co.,Ltd

K212506Medical Examination Gloves (Tested for Use with Chemotherapy)

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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