Cleared Traditional

K813088 - DESERET NEOLON SURGICAL GLOVES

K813088 is the FDA 510(k) clearance for DESERET NEOLON SURGICAL GLOVES by Warner-Lambert Co.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K813088 · Warner-Lambert Co. · General Hospital
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Dec 1981
Decision
42d
Days
Class 1
Risk

K813088 is an FDA 510(k) clearance for the DESERET NEOLON SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on December 14, 1981 after a review of 42 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 Warner-Lambert Co. devices

Submission Details

510(k) Number K813088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1981
Decision Date December 14, 1981
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 K813088.
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
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