Cleared Traditional

STERILE DISPOSABLE SURGICAL GLOVES (K812421) - FDA 510(k) Clearance

Class I General Hospital device.

K812421 · Intermarket Latex, Inc. · General Hospital
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Feb 1982
Decision
170d
Days
Class 1
Risk

K812421 is an FDA 510(k) clearance for the STERILE DISPOSABLE SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Intermarket Latex, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1982 after a review of 170 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 Intermarket Latex, Inc. devices

Submission Details

510(k) Number K812421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1981
Decision Date February 10, 1982
Days to Decision 170 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
41d slower than avg
Panel avg: 129d · This submission: 170d
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 97
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K812421.
BDAC OMICRON PLUS SURGICAL GLOVES
K885271 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1989
SURGEON'S GLOVES
K842884 · Travenol Laboratories, S.A. · Nov 1984
TRIFLEX SURGEON'S GLOVES
K832448 · Travenol Laboratories, S.A. · Jan 1984
RADIATION STERILIZED SURGEON'S GLOVES
K813565 · Travenol Laboratories, S.A. · Jan 1982
SURGEON'S GLOVES
K811753 · Travenol Laboratories, S.A. · Sep 1981
GLOVES, STERILE LATEX SURGEON'S
K760243 · Travenol Laboratories, S.A. · Aug 1976