Cleared Traditional

K123760 - MULTIPLE NAME

K123760 is an FDA 510(k) clearance for MULTIPLE NAME, manufactured by Assurguard Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K123760 · Assurguard Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
52d
Days
Class 1
Risk

K123760 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 Assurguard Sdn. Bhd. (Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on January 28, 2013 after a review of 52 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.

FDA 510(k) Submission Details - K123760

510(k) Number K123760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2012
Decision Date January 28, 2013
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
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 1176
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K123760.
CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)
K123116 · Worldmed Manufacturing Sdn. Bhd. · Feb 2013
LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE
K123488 · Puyang Linshi Health Co., Ltd. · Feb 2013
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
K122696 · Cardinal Health, Inc. · Jan 2013
POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
K121592 · Tekmedic (M) Sdn Bhd · Jan 2013
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
K123328 · Nitrilist Gloves Manufacturing Sdn Bhd · Jan 2013
POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)
K122408 · Hongye Plastic Products Co., Ltd. · Jan 2013