Cleared Traditional

Latex Examination Gloves, Powder Free

K213509 · Shandong Intco Medical Products Co, Ltd. · General Hospital

Apr 2022

Decision

157d

Days

Class 1

Risk

About This 510(k) Submission

K213509 is an FDA 510(k) clearance for the Latex Examination Gloves, Powder Free, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Shandong Intco Medical Products Co, Ltd. (Qingzhou, CN). The FDA issued a Cleared decision on April 8, 2022, 157 days after receiving the submission on November 2, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K213509 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2021
Decision Date	April 08, 2022
Days to Decision	157 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

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.