Cleared Traditional

NITRILE GLOVES

K970135 · Sage Products, Inc. · General Hospital

Aug 1997

Decision

222d

Days

Class 1

Risk

About This 510(k) Submission

K970135 is an FDA 510(k) clearance for the NITRILE GLOVES, a Medical Glove, Specialty (Class I — General Controls, product code LZC), submitted by Sage Products, Inc. (Crystal Lake, US). The FDA issued a Cleared decision on August 25, 1997, 222 days after receiving the submission on January 15, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K970135 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 15, 1997
Decision Date	August 25, 1997
Days to Decision	222 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	LZC — Medical Glove, Specialty
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Disposable Medical Glove (examination Or Surgeon?s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.