Cleared Abbreviated

K111923 - SKIN GUARD

K111923 is the FDA 510(k) clearance for SKIN GUARD by Pt. Intan Hevea Industry. It is a Class 1 General Hospital device (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

Submission Details

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
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 129d · This submission: 120d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 150
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K111923.
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
K161006 · Hartalega Sdn Bhd · Aug 2016
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
K133953 · Hartalega Sdn Bhd · May 2014
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
K123368 · Hartalega Sdn Bhd · May 2013
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM
K103602 · Medline Industries, Inc. · Apr 2011
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
K100907 · Siam Sempermed Corp., Ltd. · Jul 2010
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
K100211 · Shen Wei (Usa), Inc. · May 2010