Cleared Traditional

K922769 - STERILE SURGEONS GLOVES -- MODIFICATION

K922769 is an FDA 510(k) clearance for STERILE SURGEONS GLOVES -- MODIFICATION, manufactured by Real Latex Pvt. , Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K922769 · Real Latex Pvt. , Ltd. · General Hospital
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Oct 1992
Decision
143d
Days
Class 1
Risk

K922769 is an FDA 510(k) clearance for the STERILE SURGEONS GLOVES -- MODIFICATION. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Real Latex Pvt. , Ltd. (Bombay, Maharashtra, IN). The FDA issued a Cleared decision on October 6, 1992 after a review of 143 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 Real Latex Pvt. , Ltd. devices

FDA 510(k) Submission Details - K922769

510(k) Number K922769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1992
Decision Date October 06, 1992
Days to Decision 143 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 129d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

KGO Device Classification - Class 1, General Controls

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 375
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K922769.
EUDERMIC POWDER-FREE SURGICAL GLOVES
K915807 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1992
DEXTRON SURGICAL GLOVES
K921804 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1992
RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE
K913893 · Depuy, Inc. · Oct 1992
HYPOALLERGENIC SURGEON'S GLOVES - STERILE
K914824 · Wembley Rubber Products (M) Sdn Bhd · Jan 1992
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