Decision Date2023-01-13
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
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.
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. 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.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: LZA)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K262208Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid – Blue;Non-sterile, Powder Free Nitrile Examination Gloves - PinkYty Industry (Manjung) Sdn BhdK261793Powder-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 CitrateCardinalhealthK260794NON-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
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.