Cleared Abbreviated

Non-sterile, Powder-Free Latex Examination Glove

K212309 · Sri Trang Gloves (Thailand) Public Company Limited · General Hospital
Apr 2022
Decision
259d
Days
Class 1
Risk

About This 510(k) Submission

K212309 is an FDA 510(k) clearance for the Non-sterile, Powder-Free Latex Examination Glove, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Sri Trang Gloves (Thailand) Public Company Limited (Hatyai, TH). The FDA issued a Cleared decision on April 8, 2022, 259 days after receiving the submission on July 23, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K212309 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2021
Decision Date April 08, 2022
Days to Decision 259 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code LYY — Latex Patient Examination Glove
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.

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