Cleared Traditional

K884425 - GLOVE, SURGICAL

K884425 is an FDA 510(k) clearance for GLOVE, manufactured by Med-Pak Corp.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K884425 · Med-Pak Corp. · General Hospital
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Feb 1989
Decision
109d
Days
Class 1
Risk

K884425 is an FDA 510(k) clearance for the GLOVE, SURGICAL. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Med-Pak Corp. (Canada H4r 2k3, CA). The FDA issued a Cleared decision on February 6, 1989 after a review of 109 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 Med-Pak Corp. devices

FDA 510(k) Submission Details - K884425

510(k) Number K884425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1988
Decision Date February 06, 1989
Days to Decision 109 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
20d faster than avg
Panel avg: 129d · This submission: 109d
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 379
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K884425.
POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES
K895669 · Safeskin Corp. · Nov 1989
SAFESKIN POWDRED HYPOALLERGENIC STERIL SURG GLOVES
K894354 · Safeskin Corp. · Aug 1989
BDAC OMICRON PLUS SURGICAL GLOVES
K885271 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1989
BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES
K882392 · Roseburg SA · Aug 1988
PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI
K882381 · Pioneering Technologies, Inc. · Jul 1988
SAFESKIN STERILE SURGEONS GLOVES
K880446 · Safeskin Corp. · Jun 1988