Non-sterile, Powder-Free Latex Examination Glove
K-Number: K212309 · 2022-04-08
Decision Date2022-04-08
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Non-sterile, Powder-Free Latex Examination Glove is a medical device manufactured by Sri Trang Gloves (Thailand) Public Company Limited. It received FDA 510(k) clearance on 2022-04-08 under approval number K212309. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Non-sterile, Powder-Free Latex Examination Glove?
Non-sterile, Powder-Free Latex Examination Glove is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by Sri Trang Gloves (Thailand) Public Company Limited. The 510(k) number is K212309.
When was Non-sterile, Powder-Free Latex Examination Glove approved by the FDA?
Non-sterile, Powder-Free Latex Examination Glove received FDA 510(k) clearance on 2022-04-08, under approval number K212309.
What company makes Non-sterile, Powder-Free Latex Examination Glove?
Non-sterile, Powder-Free Latex Examination Glove is manufactured by Sri Trang Gloves (Thailand) Public Company Limited.
What is the FDA product code for Non-sterile, Powder-Free Latex Examination Glove?
The FDA product code for Non-sterile, Powder-Free Latex Examination Glove is LYY.
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 Sri Trang Gloves (Thailand) Public Company Limited
K200539Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
K193581Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster
K221165Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl
K212482Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)
K232614Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)
Related Devices (Code: LYY)
K162175Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or lessVietglove Corporation
K161006Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of GloveHartalega Sdn Bhd
K153744A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)A1 Glove Sdn Bhd
K152593LATEX EXAMINATION GLOVE POWDER FREECareplus (M) Sdn Bhd
K170094POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATEDVietglove Corporation
K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable proteinTerang Nusa 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.