FDA 510(k)

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

Numéro K : K152937 · 2016-06-23

Date de décision2016-06-23

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented is the device name listed in this FDA 510(k) record. The listed applicant is Eco Medi Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K152937. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Eco Medi Glove Sdn. Bhd.. The 510(k) number is K152937.

When did EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented receive FDA 510(k) clearance?

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

Who is the listed applicant for EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented?

The FDA 510(k) record lists Eco Medi Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Dispositifs connexes (Code : LZA)

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Source officielle

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