Cleared Abbreviated

Latex Examination Glove Powder Free (Ocean Blue and Natural White)

K240266 · Sri Trang Gloves (Thailand) Public Company Limited · General Hospital
Sep 2024
Decision
222d
Days
Class 1
Risk

About This 510(k) Submission

K240266 is an FDA 510(k) clearance for the Latex Examination Glove Powder Free (Ocean Blue and Natural White), 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 September 9, 2024, 222 days after receiving the submission on January 31, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K240266 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2024
Decision Date September 09, 2024
Days to Decision 222 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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