Cleared Traditional

K802641 - GAMMEX SURGICAL GLOVES

K802641 is the FDA 510(k) clearance for GAMMEX SURGICAL GLOVES by Ansell, Inc.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K802641 · Ansell, Inc. · General Hospital
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Dec 1980
Decision
48d
Days
Class 1
Risk

K802641 is an FDA 510(k) clearance for the GAMMEX SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Ansell, Inc. (Dothan, US). The FDA issued a Cleared decision on December 11, 1980 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ansell, Inc. devices

Submission Details

510(k) Number K802641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1980
Decision Date December 11, 1980
Days to Decision 48 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
81d faster than avg
Panel avg: 129d · This submission: 48d
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 169
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K802641.
RADIATION STERILIZED SURGEON'S GLOVES
K813565 · Travenol Laboratories, S.A. · Jan 1982
DESERET NEOLON SURGICAL GLOVES
K813088 · Warner-Lambert Co. · Dec 1981
SURGEON'S GLOVES
K811753 · Travenol Laboratories, S.A. · Sep 1981
SURGIKOS NEUTRALON BR. SURGEON'S GLOVE
K800152 · Surgikos, Inc. · Feb 1980
SUBCLAVIAN TRAY
K780419 · Concord Laboratories, Inc. · Mar 1978
DRESSING CHANGE KIT
K760912 · American Hospital Supply Corp. · Dec 1976