Cleared Special

K142685 - NITRILE EXAMINATION GLOVES WITH ALOE & ...

K142685 is the FDA 510(k) clearance for NITRILE EXAMINATION GLOVES WITH ALOE & ... by Siam Sempermed Corp., Ltd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Special 510(k) pathway after a 142-day FDA review.

K142685 · Siam Sempermed Corp., Ltd. · General Hospital
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Feb 2015
Decision
142d
Days
Class 1
Risk

K142685 is an FDA 510(k) clearance for the NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Siam Sempermed Corp., Ltd. (Hatyai, TH). The FDA issued a Cleared decision on February 11, 2015 after a review of 142 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siam Sempermed Corp., Ltd. devices

Submission Details

510(k) Number K142685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2014
Decision Date February 11, 2015
Days to Decision 142 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 129d · This submission: 142d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 498
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K142685.
U-MED Powder Free Polyethylene Examination Gloves,Blue Color
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