Cleared Abbreviated

K111923 - SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE

K111923 is an FDA 510(k) clearance for SKIN GUARD, manufactured by Pt. Intan Hevea Industry. The device is a Class 1 General Hospital device with product code LYY cleared through the Abbreviated 510(k) pathway after a 120-day FDA review.

K111923 · Pt. Intan Hevea Industry · General Hospital
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Nov 2011
Decision
120d
Days
Class 1
Risk

K111923 is an FDA 510(k) clearance for the SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt. Intan Hevea Industry (Sudarso Km. 10,5, Medan, ID). The FDA issued a Cleared decision on November 4, 2011 after a review of 120 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Pt. Intan Hevea Industry devices

FDA 510(k) Submission Details - K111923

510(k) Number K111923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2011
Decision Date November 04, 2011
Days to Decision 120 days
Submission Type Abbreviated
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
9d faster than avg
Panel avg: 129d · This submission: 120d
Pathway characteristics
Standards-based clearance path.

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 633
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K111923.
NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K112005 · Ug Healthcare (Usa), Inc. · Mar 2012
POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
K112612 · Top Calibre Sdn Bhd · Jan 2012
POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE
K112988 · Northstar Healthcare Holdings Limited · Nov 2011
MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES
K110250 · Total Gloves Sdn Bhd · Oct 2011
LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K111158 · Innovative Gloves Co;, Ltd. · Aug 2011
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)
K111133 · Ssc Surat Thani · Jun 2011