Powder Free Nitrile Examination Glove, Non-sterile (Blue)
K-Number: K220209 · 2022-04-11
ApplicantKsg Medicare Sdn. Bhd.
Decision Date2022-04-11
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Powder Free Nitrile Examination Glove, Non-sterile (Blue) is a medical device manufactured by Ksg Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 2022-04-11 under approval 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. It is manufactured by Ksg Medicare Sdn. Bhd.. The 510(k) number is K220209.
When was Powder Free Nitrile Examination Glove, Non-sterile (Blue) approved by the FDA?
Powder Free Nitrile Examination Glove, Non-sterile (Blue) received FDA 510(k) clearance on 2022-04-11, under approval number K220209.
What company makes Powder Free Nitrile Examination Glove, Non-sterile (Blue)?
Powder Free Nitrile Examination Glove, Non-sterile (Blue) is manufactured by Ksg Medicare Sdn. Bhd..
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
NCT06968845
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
RECRUITING
NCT07247825
Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy.
RECRUITING
NCT06849856
Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches
COMPLETED
Other Devices by Ksg Medicare Sdn. Bhd.
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)
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)
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.