Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black
K-Number: K220121 · 2022-04-11
ApplicantAamedix Glove Sdn Bhd
Decision Date2022-04-11
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black is a medical device manufactured by Aamedix Glove Sdn Bhd. It received FDA 510(k) clearance on 2022-04-11 under approval number K220121. 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 Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black?
Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black is a medical device that received FDA 510(k) clearance on 2022-04-11. It is manufactured by Aamedix Glove Sdn Bhd. The 510(k) number is K220121.
When was Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black approved by the FDA?
Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black received FDA 510(k) clearance on 2022-04-11, under approval number K220121.
What company makes Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black?
Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black is manufactured by Aamedix Glove Sdn Bhd.
What is the FDA product code for Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black?
The FDA product code for Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black 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
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.