Cleared Traditional

K022784 - SYNTEX POWDER-FREE NITRILE EXAMINATION ...

K022784 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 83-day FDA review.

K022784 · Syntex Healthcare Products Co., Ltd. · General Hospital
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Nov 2002
Decision
83d
Days
Class 1
Risk

K022784 is an FDA 510(k) clearance for the SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Syntex Healthcare Products Co., Ltd. (Xinji City, Hebei Province, CN). The FDA issued a Cleared decision on November 13, 2002 after a review of 83 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 - K022784

510(k) Number K022784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2002
Decision Date November 13, 2002
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 K022784.
POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
K024184 · Perusahaan Getah Asas Sdn. Bhd. · Jan 2003
DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE
K023517 · Wrp Asia Pacific Sdn. Bhd. · Dec 2002
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
K022671 · Hartalega Sdn Bhd · Nov 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K022765 · Allegiance Healthcare Corp. · Oct 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K023170 · Allegiance Healthcare Corp. · Oct 2002
DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
K022904 · Wrp Asia Pacific Sdn. Bhd. · Oct 2002