Cleared Traditional

K823086 - DESERET SURGEON'S GLOVE ACCESSORY

K823086 is an FDA 510(k) clearance for DESERET SURGEON'S GLOVE ACCESSORY, manufactured by Parke-Davis Co.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K823086 · Parke-Davis Co. · General Hospital
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Jan 1983
Decision
90d
Days
Class 1
Risk

K823086 is an FDA 510(k) clearance for the DESERET SURGEON'S GLOVE ACCESSORY. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Parke-Davis Co. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1983 after a review of 90 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.

View all Parke-Davis Co. devices

FDA 510(k) Submission Details - K823086

510(k) Number K823086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1982
Decision Date January 17, 1983
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 281
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K823086.
TRIFLEX SURGEON'S GLOVES
K832448 · Travenol Laboratories, S.A. · Jan 1984
VANISH II
K833093 · Warner-Lambert Co. · Dec 1983
MICRO-THIN SURGICAL GLOVE
K831565 · Ansell, Inc. · Jul 1983
DERMA PRENE
K820665 · Ansell, Inc. · May 1982
RADIATION STERILIZED SURGEON'S GLOVES
K813565 · Travenol Laboratories, S.A. · Jan 1982
DESERET NEOLON SURGICAL GLOVES
K813088 · Warner-Lambert Co. · Dec 1981