FDA 510(k)

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid

Numéro K : K233560 · 2024-02-26

Date de décision2024-02-26

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid 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 2024-02-26 under 510(k) number K233560. 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 Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid?

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is a medical device that received FDA 510(k) clearance on 2024-02-26. The listed applicant is Eco Medi Glove Sdn. Bhd.. The 510(k) number is K233560.

When did Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid receive FDA 510(k) clearance?

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid received FDA 510(k) clearance on 2024-02-26, under 510(k) number K233560.

Who is the listed applicant for Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid?

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 Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid?

The FDA product code for Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is LZA.

Essais cliniques associés

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

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 K220943Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug 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)

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Source officielle

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