FDA 510(k)

Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black

Numéro K : K220121 · 2022-04-11

Date de décision2022-04-11

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black is the device name listed in this FDA 510(k) record. The listed applicant is Aamedix Glove Sdn Bhd. It received FDA 510(k) clearance on 2022-04-11 under 510(k) number K220121. 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 Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black?

Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black is a medical device that received FDA 510(k) clearance on 2022-04-11. The listed applicant is Aamedix Glove Sdn Bhd. The 510(k) number is K220121.

When did Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black receive FDA 510(k) clearance?

Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black received FDA 510(k) clearance on 2022-04-11, under 510(k) number K220121.

Who is the listed applicant for Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black?

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

What is the FDA product code for Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black?

The FDA product code for Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black is LZA.

Essais cliniques associés

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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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