Cleared Traditional

K981096 - SEMPERMED SURGEONS' GLOVES - SUPREME

K981096 is an FDA 510(k) clearance for SEMPERMED SURGEONS' GLOVES - SUPREME, manufactured by Semperit Technische Produkte Gesellshaft. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K981096 · Semperit Technische Produkte Gesellshaft · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
218d
Days
Class 1
Risk

K981096 is an FDA 510(k) clearance for the SEMPERMED SURGEONS' GLOVES - SUPREME. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Semperit Technische Produkte Gesellshaft (Vienna, AT). The FDA issued a Cleared decision on October 29, 1998 after a review of 218 days - an extended review cycle.

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 Semperit Technische Produkte Gesellshaft devices

FDA 510(k) Submission Details - K981096

510(k) Number K981096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1998
Decision Date October 29, 1998
Days to Decision 218 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 129d · This submission: 218d
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 294
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K981096.
OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE
K984064 · Omni Intl., Inc. · Jan 1999
ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)
K983489 · Ansell Perry · Dec 1998
NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES
K983240 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · Nov 1998
SURGEON'S GLOVE
K982589 · Shiva Medicare , Ltd. · Sep 1998
OMNI PRO LATEX SURGICAL GLOVE, POWDERED
K982613 · Omnigrace (Thailand) , Ltd. · Sep 1998
POWDER FREE SURGEONS GLOVE
K982586 · Shiva Medicare , Ltd. · Aug 1998