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FDA 510(k)

EMG Pink Nitrile Examination Glove Powder Free

K-Number: K161320 · 2016-09-01

ApplicantEco Medi Glove Sdn. Bhd.
Decision Date2016-09-01
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EMG Pink Nitrile Examination Glove Powder Free is a medical device manufactured by Eco Medi Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2016-09-01 under approval number K161320. 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 EMG Pink Nitrile Examination Glove Powder Free?

EMG Pink Nitrile Examination Glove Powder Free is a medical device that received FDA 510(k) clearance on 2016-09-01. It is manufactured by Eco Medi Glove Sdn. Bhd.. The 510(k) number is K161320.

When was EMG Pink Nitrile Examination Glove Powder Free approved by the FDA?

EMG Pink Nitrile Examination Glove Powder Free received FDA 510(k) clearance on 2016-09-01, under approval number K161320.

What company makes EMG Pink Nitrile Examination Glove Powder Free?

EMG Pink Nitrile Examination Glove Powder Free is manufactured by Eco Medi Glove Sdn. Bhd..

What is the FDA product code for EMG Pink Nitrile Examination Glove Powder Free?

The FDA product code for EMG Pink Nitrile Examination Glove Powder Free 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

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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