Cleared Traditional

K832448 - TRIFLEX SURGEON'S GLOVES

K832448 is the FDA 510(k) clearance for TRIFLEX SURGEON'S GLOVES by Travenol Laboratories, S.A.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K832448 · Travenol Laboratories, S.A. · General Hospital
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Jan 1984
Decision
186d
Days
Class 1
Risk

K832448 is an FDA 510(k) clearance for the TRIFLEX SURGEON'S GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Travenol Laboratories, S.A. (Walker, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 186 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K832448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1983
Decision Date January 27, 1984
Days to Decision 186 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 129d · This submission: 186d
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 164
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K832448.
NEUTRALON SURGICAL GLOVES
K861441 · Surgikos, Inc. · May 1986
SURGEON'S GLOVES
K842884 · Travenol Laboratories, S.A. · Nov 1984
VANISH
K833976 · Parke-Davis Co. · Feb 1984
VANISH II
K833093 · Warner-Lambert Co. · Dec 1983
DESERET SURGEON'S GLOVE ACCESSORY
K823086 · Parke-Davis Co. · Jan 1983
RADIATION STERILIZED SURGEON'S GLOVES
K813565 · Travenol Laboratories, S.A. · Jan 1982