Cleared Abbreviated

K111133 - NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)

K111133 is an FDA 510(k) clearance for NON-STERILE, manufactured by Ssc Surat Thani. The device is a Class 1 General Hospital device with product code LYY cleared through the Abbreviated 510(k) pathway after a 63-day FDA review.

K111133 · Ssc Surat Thani · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
63d
Days
Class 1
Risk

K111133 is an FDA 510(k) clearance for the NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG O.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Ssc Surat Thani (Clearwater, US). The FDA issued a Cleared decision on June 24, 2011 after a review of 63 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 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 Ssc Surat Thani devices

FDA 510(k) Submission Details - K111133

510(k) Number K111133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2011
Decision Date June 24, 2011
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
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 410
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K111133.
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