Cleared Special

K142685 - NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE

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

K142685 · Siam Sempermed Corp., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K142685

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 129d · This submission: 142d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Sempermed USA, Inc.
JOHN CALHOUN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

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