Cleared Traditional

K123757 - POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR

K123757 is an FDA 510(k) clearance for POWDER FREE LATEX PATIENT EXAMINATION G..., manufactured by Assurguard Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K123757 · Assurguard Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2013
Decision
56d
Days
Class 1
Risk

K123757 is an FDA 510(k) clearance for the POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING C.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Assurguard Sdn. Bhd. (Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on February 1, 2013 after a review of 56 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 Assurguard Sdn. Bhd. devices

FDA 510(k) Submission Details - K123757

510(k) Number K123757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2012
Decision Date February 01, 2013
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 402
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K123757.
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