Cleared Traditional

K833093 - VANISH II

K833093 is the FDA 510(k) clearance for VANISH II by Warner-Lambert Co.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K833093 · Warner-Lambert Co. · General Hospital
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Dec 1983
Decision
91d
Days
Class 1
Risk

K833093 is an FDA 510(k) clearance for the VANISH II. 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 12, 1983 after a review of 91 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 Warner-Lambert Co. devices

Submission Details

510(k) Number K833093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1983
Decision Date December 12, 1983
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 K833093.
SURGEON'S GLOVES
K842884 · Travenol Laboratories, S.A. · Nov 1984
VANISH
K833976 · Parke-Davis Co. · Feb 1984
TRIFLEX SURGEON'S GLOVES
K832448 · Travenol Laboratories, S.A. · Jan 1984
DESERET SURGEON'S GLOVE ACCESSORY
K823086 · Parke-Davis Co. · Jan 1983
RADIATION STERILIZED SURGEON'S GLOVES
K813565 · Travenol Laboratories, S.A. · Jan 1982
DESERET NEOLON SURGICAL GLOVES
K813088 · Warner-Lambert Co. · Dec 1981