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FDA 510(k)

EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented

K-Number: K152937 · 2016-06-23

ApplicantEco Medi Glove Sdn. Bhd.
Decision Date2016-06-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented is a medical device manufactured by Eco Medi Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2016-06-23 under approval number K152937. 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 Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented?

EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented is a medical device that received FDA 510(k) clearance on 2016-06-23. It is manufactured by Eco Medi Glove Sdn. Bhd.. The 510(k) number is K152937.

When was EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented approved by the FDA?

EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented received FDA 510(k) clearance on 2016-06-23, under approval number K152937.

What company makes EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented?

EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented is manufactured by Eco Medi Glove Sdn. Bhd..

What is the FDA product code for EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented?

The FDA product code for EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented is LZA.

Related Clinical Trials

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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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