Cleared Traditional

K030157 - POWDER FREE LATEX EXAMINATION GLOVES

K030157 is the FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION GLOVES by Wrp Asia Pacific Sdn. Bhd.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K030157 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
34d
Days
Class 1
Risk

K030157 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING C.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on February 19, 2003 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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

Submission Details

510(k) Number K030157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2003
Decision Date February 19, 2003
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes 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 - LYY Latex Patient Examination Glove

All 149
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K030157.
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
K050277 · Hartalega Sdn Bhd · Jun 2005
DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI
K040645 · Wrp Asia Pacific Sdn. Bhd. · Apr 2004
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE
K030583 · Shen Wei (Usa), Inc. · Nov 2003
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL
K023490 · Wrp Asia Pacific Sdn. Bhd. · Jan 2003
MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
K024292 · Allegiance Healthcare Corp. · Jan 2003
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIM
K024106 · Siam Sempermed Corp., Ltd. · Dec 2002