Cleared Traditional

LATEX PATIENT EXAMINATION GLOVES

K911081 · Medical Device Inspection Co., Inc. · General Hospital

Mar 1991

Decision

10d

Days

Class 1

Risk

About This 510(k) Submission

K911081 is an FDA 510(k) clearance for the LATEX PATIENT EXAMINATION GLOVES, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on March 21, 1991, 10 days after receiving the submission on March 11, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K911081 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 1991
Decision Date	March 21, 1991
Days to Decision	10 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—

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.