Cleared Traditional

K023866 - POWDER FREE POLYMER COATED (ACRYLIC BAS...

K023866 is an FDA 510(k) clearance for POWDER FREE POLYMER COATED (ACRYLIC BAS..., manufactured by Kl-Kepong Rubber Products Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K023866 · Kl-Kepong Rubber Products Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
65d
Days
Class 1
Risk

K023866 is an FDA 510(k) clearance for the POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Kl-Kepong Rubber Products Sdn. Bhd. (Ipoh, Perak, Darul Ridzuan, MY). The FDA issued a Cleared decision on January 24, 2003 after a review of 65 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 Kl-Kepong Rubber Products Sdn. Bhd. devices

FDA 510(k) Submission Details - K023866

510(k) Number K023866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2002
Decision Date January 24, 2003
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

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 270
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K023866.
NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN
K030164 · Yty Industry (Manjung) Sdn Bhd · Mar 2003
POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM
K030157 · Wrp Asia Pacific Sdn. Bhd. · Feb 2003
EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE
K024355 · Yty Industry (Manjung) Sdn Bhd · Feb 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