FDA 510(k)

EMG Pink Nitrile Examination Glove Powder Free

Numéro K : K161320 · 2016-09-01

Date de décision2016-09-01

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

EMG Pink Nitrile Examination Glove Powder Free 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 2016-09-01 under 510(k) number K161320. 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 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. The listed applicant is Eco Medi Glove Sdn. Bhd.. The 510(k) number is K161320.

When did EMG Pink Nitrile Examination Glove Powder Free receive FDA 510(k) clearance?

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

Who is the listed applicant for EMG Pink Nitrile Examination Glove Powder Free?

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 Pink Nitrile Examination Glove Powder Free?

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

Essais cliniques associés

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Autres dossiers indiquant Eco Medi Glove Sdn. Bhd. en tant que demandeur

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Dispositifs connexes (Code : LZA)

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Source officielle

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