Cleared Traditional

K103337 - MULTIPLE NAME

K103337 is an FDA 510(k) clearance for MULTIPLE NAME, manufactured by Ideal Quality Sdn., Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K103337 · Ideal Quality Sdn., Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
102d
Days
Class 1
Risk

K103337 is an FDA 510(k) clearance for the MULTIPLE NAME. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ideal Quality Sdn., Bhd. (Klang, MY). The FDA issued a Cleared decision on February 25, 2011 after a review of 102 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ideal Quality Sdn., Bhd. devices

FDA 510(k) Submission Details - K103337

510(k) Number K103337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2010
Decision Date February 25, 2011
Days to Decision 102 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
27d faster than avg
Panel avg: 129d · This submission: 102d
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 776
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K103337.
SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
K103770 · Syntex Healthcare Products Co., Ltd. · Apr 2011
NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K110921 · Cardinal Health, Inc. · Apr 2011
NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES
K101820 · Yty Industry (Manjung) Sdn Bhd · Mar 2011
NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM
K103249 · Cardinal Health, Inc. · Dec 2010
POWDERFREE BLACK NITRILE EXAMINATION GLOVES
K102620 · Pt. Medisafe Technologies · Nov 2010
BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR)
K102880 · Brightway Holdings Sdn. Bhd. · Nov 2010