Cleared Traditional

K021119 - POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM

K021119 is an FDA 510(k) clearance for POWDERED BROWN LATEX SURGICAL GLOVES, manufactured by Wrp Asia Pacific Sdn. Bhd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K021119 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
88d
Days
Class 1
Risk

K021119 is an FDA 510(k) clearance for the POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING C.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on July 5, 2002 after a review of 88 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 Wrp Asia Pacific Sdn. Bhd. devices

FDA 510(k) Submission Details - K021119

510(k) Number K021119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2002
Decision Date July 05, 2002
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 353
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K021119.
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
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM
K021159 · Wrp Asia Pacific Sdn. Bhd. · Jul 2002
DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS
K014288 · Wrp Specialty Products Sdn. Bhd. · Feb 2002
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
K020019 · Wrp Asia Pacific Sdn. Bhd. · Jan 2002