Cleared Special

K001239 - ENCORE POWDER FREE LATEX SURGICAL GLOVE...

K001239 is an FDA 510(k) clearance for ENCORE POWDER FREE LATEX SURGICAL GLOVE..., manufactured by Ansell Perry. The device is a Class 1 General Hospital device with product code KGO cleared through the Special 510(k) pathway after a 27-day FDA review.

K001239 · Ansell Perry · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
27d
Days
Class 1
Risk

K001239 is an FDA 510(k) clearance for the ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM .... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Ansell Perry (Massillon, US). The FDA issued a Cleared decision on May 15, 2000 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ansell Perry devices

FDA 510(k) Submission Details - K001239

510(k) Number K001239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2000
Decision Date May 15, 2000
Days to Decision 27 days
Submission Type Special
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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 260
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K001239.
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0
K001924 · Allegiance Healthcare Corp. · Jul 2000
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
K000178 · Terang Nusa Sdn Bhd · May 2000
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
K000179 · Terang Nusa Sdn Bhd · May 2000
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
K000971 · Wrp Asia Pacific Sdn. Bhd. · Apr 2000
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K000295 · Ansell Perry · Feb 2000
THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR
K993857 · Ansell Perry · Jan 2000