Cleared Traditional

K912157 - HYPOALLERGENIC SURGICAL LATEX GLOVES

K912157 is an FDA 510(k) clearance for HYPOALLERGENIC SURGICAL LATEX GLOVES, manufactured by Medigloves , Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K912157 · Medigloves , Ltd. · General Hospital
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Sep 1991
Decision
113d
Days
Class 1
Risk

K912157 is an FDA 510(k) clearance for the HYPOALLERGENIC SURGICAL LATEX GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Medigloves , Ltd. (Pathumtani, TH). The FDA issued a Cleared decision on September 6, 1991 after a review of 113 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.

FDA 510(k) Submission Details - K912157

510(k) Number K912157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1991
Decision Date September 06, 1991
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
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 551
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K912157.
SEVACARE STERILE SURGEON'S GLOVES
K912478 · Sevaids Industries · Sep 1991
SURGIFIT STERILE SURGICAL GLOVES
K913215 · Hevealactics Intl. Sdn Bhd · Sep 1991
TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE
K913207 · Baxter Healthcare Corp · Sep 1991
SURGICAL GLOVES
K910895 · Influx Pacific Sdn. Bhd. · Jul 1991
PERRY NATURAL POWDER FREE GLOVES
K912797 · Smith & Nephew, Inc. · Jul 1991
SURGICAL GLOVES
K911134 · Kenwell International , Ltd. · Jul 1991
K912157 · HYPOALLERGENIC SURGICAL LATEX GLOVES
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