Cleared Traditional

SURGICARE STERILE SURGICAL GLOVES (K904972) - FDA 510(k) Clearance

Class I General Hospital device.

K904972 · Kanam Latex Industries Pvt. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1991
Decision
99d
Days
Class 1
Risk

K904972 is an FDA 510(k) clearance for the SURGICARE STERILE SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Kanam Latex Industries Pvt. , Ltd. (Kottayam, Kerala, IN). The FDA issued a Cleared decision on January 31, 1991 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Kanam Latex Industries Pvt. , Ltd. devices

Submission Details

510(k) Number K904972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1990
Decision Date January 31, 1991
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGO Surgeon's Gloves

All 97
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K904972.
TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE
K913207 · Baxter Healthcare Corp · Sep 1991
PERRY NATURAL POWDER FREE GLOVES
K912797 · Smith & Nephew, Inc. · Jul 1991
EUDERMIC SURGICAL GLOVES
K911245 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1991
TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED
K903987 · Baxter Healthcare Corp · Oct 1990
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K902380 · Baxter Healthcare Corp · Jun 1990
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K897192 · Baxter Healthcare Corp · Feb 1990