Cleared Traditional

K041004 - ILLUSION POWDER FREE-POLYMER COATED COL...

K041004 is the FDA 510(k) clearance for ILLUSION POWDER FREE-POLYMER COATED COL... by Purna Bina Sdn Bhd. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K041004 · Purna Bina Sdn Bhd · General Hospital
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Jul 2004
Decision
74d
Days
Class 1
Risk

K041004 is an FDA 510(k) clearance for the ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Purna Bina Sdn Bhd (Kluang, Johor D. Takzim, MY). The FDA issued a Cleared decision on July 2, 2004 after a review of 74 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 Purna Bina Sdn Bhd devices

Submission Details

510(k) Number K041004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2004
Decision Date July 02, 2004
Days to Decision 74 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 129d · This submission: 74d
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 150
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K041004.
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)
K081907 · Siam Sempermed Corp., Ltd. · Sep 2008
STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)
K051329 · Siam Sempermed Corp., Ltd. · Jul 2005
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
POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM
K030157 · Wrp Asia Pacific Sdn. Bhd. · Feb 2003