Cleared Traditional

K962724 - STERILE LATEX SURGICAL, SOLD UNDER BRAND NAMES SAVACARE AND ROGUMED

K962724 is an FDA 510(k) clearance for STERILE LATEX SURGICAL, manufactured by Sonnheim Medikal GmbH. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K962724 · Sonnheim Medikal GmbH · General Hospital
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Oct 1996
Decision
106d
Days
Class 1
Risk

K962724 is an FDA 510(k) clearance for the STERILE LATEX SURGICAL, SOLD UNDER BRAND NAMES SAVACARE AND ROGUMED. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Sonnheim Medikal GmbH (Zeulenroda, DE). The FDA issued a Cleared decision on October 29, 1996 after a review of 106 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 - K962724

510(k) Number K962724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1996
Decision Date October 29, 1996
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 129d · This submission: 106d
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 520
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K962724.
DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES
K962813 · Maxxim Medical · Jan 1997
GLOVEL GX
K963020 · Kenwell International , Ltd. · Nov 1996
BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE
K963218 · American Bantex Corp. · Oct 1996
NULIFE
K962837 · Med-Tech Rubber & Engineering Industries · Oct 1996
MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES
K962986 · Johnson & Johnson Medical, Inc. · Sep 1996
MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES
K961632 · Johnson & Johnson Medical, Inc. · Jul 1996
K962724 · STERILE LATEX SURGICAL, SOLD UNDER BRAND NAMES SAVACARE AND ROGUMED
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