FDA 510(k)

DilaCheck Nitrile Powder Free Examination Glove, (Sterile)

Numéro K : K163035 · 2017-07-07

Date de décision2017-07-07

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

DilaCheck Nitrile Powder Free Examination Glove, (Sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Elm Tree Medical, Inc.. It received FDA 510(k) clearance on 2017-07-07 under 510(k) number K163035. 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 DilaCheck Nitrile Powder Free Examination Glove, (Sterile)?

DilaCheck Nitrile Powder Free Examination Glove, (Sterile) is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Elm Tree Medical, Inc.. The 510(k) number is K163035.

When did DilaCheck Nitrile Powder Free Examination Glove, (Sterile) receive FDA 510(k) clearance?

DilaCheck Nitrile Powder Free Examination Glove, (Sterile) received FDA 510(k) clearance on 2017-07-07, under 510(k) number K163035.

Who is the listed applicant for DilaCheck Nitrile Powder Free Examination Glove, (Sterile)?

The FDA 510(k) record lists Elm Tree Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DilaCheck Nitrile Powder Free Examination Glove, (Sterile)?

The FDA product code for DilaCheck Nitrile Powder Free Examination Glove, (Sterile) is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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