Cleared Traditional

K962813 - DEXTREN CLEAR POWDER-FREE HYPOALLERGENI...

K962813 is an FDA 510(k) clearance for DEXTREN CLEAR POWDER-FREE HYPOALLERGENI..., manufactured by Maxxim Medical. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K962813 · Maxxim Medical · General Hospital
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Jan 1997
Decision
195d
Days
Class 1
Risk

K962813 is an FDA 510(k) clearance for the DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Maxxim Medical (Clearwater, US). The FDA issued a Cleared decision on January 30, 1997 after a review of 195 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 Maxxim Medical devices

FDA 510(k) Submission Details - K962813

510(k) Number K962813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1996
Decision Date January 30, 1997
Days to Decision 195 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 129d · This submission: 195d
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 241
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K962813.
ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES
K964474 · Allegiance Healthcare Corp. · Mar 1997
SENTURA SURGICAL GLOVES
K964962 · Maxxim Medical · Mar 1997
ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM
K964980 · Maxxim Medical · Mar 1997
MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES
K962986 · Johnson & Johnson Medical, Inc. · Sep 1996
MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES
K961632 · Johnson & Johnson Medical, Inc. · Jul 1996
NEOLON NEOPRENE SURGICAL GLOVES
K954325 · Maxxim Medical · May 1996