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FDA 510(k)

EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs

K-Number: K171339 · 2017-07-07

ApplicantEco Medi Glove Sdn. Bhd.
Decision Date2017-07-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs is a medical device manufactured by Eco Medi Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2017-07-07 under approval number K171339. 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 Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs?

EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-07-07. It is manufactured by Eco Medi Glove Sdn. Bhd.. The 510(k) number is K171339.

When was EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs approved by the FDA?

EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs received FDA 510(k) clearance on 2017-07-07, under approval number K171339.

What company makes EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs?

EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs is manufactured by Eco Medi Glove Sdn. Bhd..

What is the FDA product code for EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs?

The FDA product code for EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs is LZA.

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Related PubMed Literature

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Other Devices by Eco Medi Glove Sdn. Bhd.

K161187EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs K161320EMG Pink Nitrile Examination Glove Powder Free K152937EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims K193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims K202401Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein

View all 11 devices →

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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