FDA 510(k)

Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim

Numéro K : K220943 · 2022-07-19

Date de décision2022-07-19

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim 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 2022-07-19 under 510(k) number K220943. 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 Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim?

Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim is a medical device that received FDA 510(k) clearance on 2022-07-19. The listed applicant is Eco Medi Glove Sdn. Bhd.. The 510(k) number is K220943.

When did Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim receive FDA 510(k) clearance?

Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim received FDA 510(k) clearance on 2022-07-19, under 510(k) number K220943.

Who is the listed applicant for Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim?

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 Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim?

The FDA product code for Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim is LZA.

Essais cliniques associés

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Autres dossiers indiquant Eco Medi Glove Sdn. Bhd. en tant que demandeur

K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid K232764Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K233405Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim K202401Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein K193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims

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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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