Cleared Special

K024130 - POWDER FREE POLYMER COATED GREEN NEOPRE...

K024130 is the FDA 510(k) clearance for POWDER FREE POLYMER COATED GREEN NEOPRE... by Wrp Asia Pacific Sdn. Bhd.. It is a Class 1 General Hospital device (product code KGO) cleared through the Special 510(k) pathway after a 14-day FDA review.

K024130 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
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Dec 2002
Decision
14d
Days
Class 1
Risk

K024130 is an FDA 510(k) clearance for the POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Wrp Asia Pacific Sdn. Bhd. (Salak Tinggi, Sepang Selangor, MY). The FDA issued a Cleared decision on December 30, 2002 after a review of 14 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 Wrp Asia Pacific Sdn. Bhd. devices

Submission Details

510(k) Number K024130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2002
Decision Date December 30, 2002
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 164
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K024130.
PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE
K032942 · Wrp Asia Pacific Sdn. Bhd. · Dec 2003
ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA
K032647 · Wrp Asia Pacific Sdn. Bhd. · Nov 2003
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50
K032464 · Wrp Asia Pacific Sdn. Bhd. · Aug 2003
POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA
K022444 · Wrp Asia Pacific Sdn. Bhd. · Sep 2002
POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS)
K022442 · Wrp Asia Pacific Sdn. Bhd. · Sep 2002
PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
K021784 · Wrp Asia Pacific Sdn. Bhd. · Jul 2002