Cleared Traditional

K013302 - DURAPRENE STERILE SYNTHETIC POWDER-FREE...

K013302 is an FDA 510(k) clearance for DURAPRENE STERILE SYNTHETIC POWDER-FREE..., manufactured by Allegiance Healthcare Corp.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K013302 · Allegiance Healthcare Corp. · General Hospital
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Dec 2001
Decision
75d
Days
Class 1
Risk

K013302 is an FDA 510(k) clearance for the DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE W.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Allegiance Healthcare Corp. (Mcgaw Park, US). The FDA issued a Cleared decision on December 17, 2001 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Allegiance Healthcare Corp. devices

FDA 510(k) Submission Details - K013302

510(k) Number K013302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2001
Decision Date December 17, 2001
Days to Decision 75 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 129d · This submission: 75d
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 K013302.
POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM
K021119 · Wrp Asia Pacific Sdn. Bhd. · Jul 2002
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM
K021159 · Wrp Asia Pacific Sdn. Bhd. · Jul 2002
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
K020019 · Wrp Asia Pacific Sdn. Bhd. · Jan 2002
STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G
K013727 · Smart Glove Corp. Sdn Bhd · Dec 2001
STERILE NITRILE SURGICAL GLOVES (POWDERED)
K012479 · Smart Glove Corp. Sdn Bhd · Sep 2001
STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
K011066 · Smart Glove Corp. Sdn Bhd · Sep 2001