Cleared Traditional

K944053 - NATURAL RUBBER LATEX SURGEONS GLOVE

K944053 is an FDA 510(k) clearance for NATURAL RUBBER LATEX SURGEONS GLOVE, manufactured by Arent Fox. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K944053 · Arent Fox · General Hospital
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Apr 1995
Decision
249d
Days
Class 1
Risk

K944053 is an FDA 510(k) clearance for the NATURAL RUBBER LATEX SURGEONS GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Arent Fox (Washington, US). The FDA issued a Cleared decision on April 25, 1995 after a review of 249 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 Arent Fox devices

FDA 510(k) Submission Details - K944053

510(k) Number K944053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1994
Decision Date April 25, 1995
Days to Decision 249 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 129d · This submission: 249d
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 189
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K944053.
ULTIMAX
K951473 · Wembley Rubber Products (M) Sdn Bhd · Jul 1995
PROFEEL
K951661 · Wembley Rubber Products (M) Sdn Bhd · May 1995
COMFIT/BEADED SURGEON'S GLOVE
K951662 · Wembley Rubber Products (M) Sdn Bhd · May 1995
SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED)
K943254 · Wembley Rubber Products (M) Sdn Bhd · Mar 1995
SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED)
K943255 · Wembley Rubber Products (M) Sdn Bhd · Mar 1995
MAXXUS LP ORTHOPAEDIC LATEX SURGICAL GLOVES
K945157 · Johnson & Johnson Medical, Inc. · Feb 1995