Cleared Traditional

K042226 - SYNTEX POWDER-FREE NITRILE EXAMINATION ...

K042226 is an FDA 510(k) clearance for SYNTEX POWDER-FREE NITRILE EXAMINATION ..., manufactured by Syntex Healthcare Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K042226 · Syntex Healthcare Products Co., Ltd. · General Hospital
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Sep 2004
Decision
44d
Days
Class 1
Risk

K042226 is an FDA 510(k) clearance for the SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Syntex Healthcare Products Co., Ltd. (Brea, US). The FDA issued a Cleared decision on September 30, 2004 after a review of 44 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 Syntex Healthcare Products Co., Ltd. devices

FDA 510(k) Submission Details - K042226

510(k) Number K042226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2004
Decision Date September 30, 2004
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
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 683
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K042226.
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
K050214 · Hartalega Sdn Bhd · Mar 2005
NITRILE POWDERED EXAMINATION GLOVES (WHITE)
K050215 · Hartalega Sdn Bhd · Mar 2005
NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING
K042879 · Sgmp Co., Ltd. · Jan 2005
FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K041391 · Hartalega Sdn Bhd · Jul 2004
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K040841 · Medline Industries, Inc. · Jul 2004
NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
K033887 · Yty Industry (Manjung) Sdn Bhd · Mar 2004