Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Nitrile Exam Gloves (Chemotherapy Drug Tested)

K-Number: K223748 · 2023-01-13

ApplicantUs Medical Glove Company, LLC
Decision Date2023-01-13
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Exam Gloves (Chemotherapy Drug Tested) is a medical device manufactured by Us Medical Glove Company, LLC. It received FDA 510(k) clearance on 2023-01-13 under approval number K223748. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Us Medical Glove Company, LLC. The 510(k) number is K223748.

When was Nitrile Exam Gloves (Chemotherapy Drug Tested) approved by the FDA?

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

What company makes Nitrile Exam Gloves (Chemotherapy Drug Tested)?

Nitrile Exam Gloves (Chemotherapy Drug Tested) is manufactured by Us Medical Glove Company, LLC.

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.

Related Clinical Trials

NCT06823440 Prevention of CIPN Using Compressive Therapy RECRUITING

Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑