Cleared Traditional

K063524 - POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)

K063524 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVES ..., manufactured by Hl Rubber Industries Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K063524 · Hl Rubber Industries Sdn Bhd · General Hospital
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Jan 2007
Decision
62d
Days
Class 1
Risk

K063524 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hl Rubber Industries Sdn Bhd (Kuala Pilah, Negeri Sembilan, MY). The FDA issued a Cleared decision on January 23, 2007 after a review of 62 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 Hl Rubber Industries Sdn Bhd devices

FDA 510(k) Submission Details - K063524

510(k) Number K063524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2006
Decision Date January 23, 2007
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 129d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 1172
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K063524.
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR
K070096 · Gx Corporation Sdn Bhd · Mar 2007
ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE
K063777 · Bright Element Sdn Bhd · Feb 2007
POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)
K063522 · Hl Rubber Industries Sdn Bhd · Feb 2007
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
K063046 · Hartalega Sdn Bhd · Nov 2006
STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED
K062778 · Wear Safe Malaysia Sdn. Bhd. · Oct 2006
POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE
K062138 · Molnlycke Health Care, Inc. · Oct 2006