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FDA 510(k)

Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

K-Number: K211547 · 2021-07-15

ApplicantEdma Group, LLC
Decision Date2021-07-15
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is a medical device manufactured by Edma Group, LLC. It received FDA 510(k) clearance on 2021-07-15 under approval number K211547. 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 Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)?

Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-07-15. It is manufactured by Edma Group, LLC. The 510(k) number is K211547.

When was Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) approved by the FDA?

Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-07-15, under approval number K211547.

What company makes Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)?

Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is manufactured by Edma Group, LLC.

What is the FDA product code for Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) 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 Edma Group, LLC

K211540Edma Synthetic Nitrile 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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