FDA 510(k)

Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange

Numéro K : K172867 · 2018-05-10

Date de décision2018-05-10

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange is the device name listed in this FDA 510(k) record. The listed applicant is Gmp Medicare Sdn Bhd (F25). It received FDA 510(k) clearance on 2018-05-10 under 510(k) number K172867. 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 Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange?

Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange is a medical device that received FDA 510(k) clearance on 2018-05-10. The listed applicant is Gmp Medicare Sdn Bhd (F25). The 510(k) number is K172867.

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

Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange received FDA 510(k) clearance on 2018-05-10, under 510(k) number K172867.

Who is the listed applicant for Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange?

The FDA 510(k) record lists Gmp Medicare Sdn Bhd (F25) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange?

The FDA product code for Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange is LZA.

Essais cliniques associés

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Autres dossiers indiquant Gmp Medicare Sdn Bhd (F25) en tant que demandeur

K182382Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs

Dispositifs connexes (Code : LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Source officielle

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