FDA 510(k)

DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

Numéro K : K161422 · 2016-10-20

Date de décision2016-10-20

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS is the device name listed in this FDA 510(k) record. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K161422. 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 DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS?

DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. The 510(k) number is K161422.

When did DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS receive FDA 510(k) clearance?

DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS received FDA 510(k) clearance on 2016-10-20, under 510(k) number K161422.

Who is the listed applicant for DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS?

The FDA 510(k) record lists Wrp Asia Pacific Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS?

The FDA product code for DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS is LZA.

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Source officielle

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