Decision Date2022-04-11
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Powder Free Nitrile Examination Glove, Non-sterile (Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Ksg Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 2022-04-11 under 510(k) number K220209. 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 Powder Free Nitrile Examination Glove, Non-sterile (Blue)?
Powder Free Nitrile Examination Glove, Non-sterile (Blue) is a medical device that received FDA 510(k) clearance on 2022-04-11. The listed applicant is Ksg Medicare Sdn. Bhd.. The 510(k) number is K220209.
When did Powder Free Nitrile Examination Glove, Non-sterile (Blue) receive FDA 510(k) clearance?
Powder Free Nitrile Examination Glove, Non-sterile (Blue) received FDA 510(k) clearance on 2022-04-11, under 510(k) number K220209.
Who is the listed applicant for Powder Free Nitrile Examination Glove, Non-sterile (Blue)?
The FDA 510(k) record lists Ksg Medicare 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, Non-sterile (Blue)?
The FDA product code for Powder Free Nitrile Examination Glove, Non-sterile (Blue) 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.
Other records listing Ksg Medicare Sdn. Bhd. as applicant
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.
K241745Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)K220215Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)
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.