FDA 510(k)

Nitrile Exam Gloves (Chemotherapy Drug Tested)

Numéro K : K223748 · 2023-01-13

Date de décision2023-01-13

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Nitrile Exam Gloves (Chemotherapy Drug Tested) is the device name listed in this FDA 510(k) record. The listed applicant is Us Medical Glove Company, LLC. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K223748. 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 Exam Gloves (Chemotherapy Drug Tested)?

Nitrile Exam Gloves (Chemotherapy Drug Tested) is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Us Medical Glove Company, LLC. The 510(k) number is K223748.

When did Nitrile Exam Gloves (Chemotherapy Drug Tested) receive FDA 510(k) clearance?

Nitrile Exam Gloves (Chemotherapy Drug Tested) received FDA 510(k) clearance on 2023-01-13, under 510(k) number K223748.

Who is the listed applicant for Nitrile Exam Gloves (Chemotherapy Drug Tested)?

The FDA 510(k) record lists Us Medical Glove Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Exam Gloves (Chemotherapy Drug Tested)?

The FDA product code for Nitrile Exam Gloves (Chemotherapy Drug Tested) 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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