FDA 510(k)

EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs

Numéro K : K161187 · 2016-09-09

Date de décision2016-09-09

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs 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 2016-09-09 under 510(k) number K161187. 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 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 2016-09-09. The listed applicant is Eco Medi Glove Sdn. Bhd.. The 510(k) number is K161187.

When did EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs receive FDA 510(k) clearance?

EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs received FDA 510(k) clearance on 2016-09-09, under 510(k) number K161187.

Who is the listed applicant for EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs?

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 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.

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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