Cleared Abbreviated

K212482 - Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
(FDA 510(k) Clearance)

K212482 · Sri Trang Gloves (Thailand) Public Company Limited · General Hospital

Aug 2022

Decision

365d

Days

Class 1

Risk

K212482 is an FDA 510(k) clearance for the Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black 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 August 9, 2022, 365 days after receiving the submission on August 9, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K212482 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 2021
Decision Date	August 09, 2022
Days to Decision	365 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.