Cleared Abbreviated

K113710 - DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR

K113710 is an FDA 510(k) clearance for DISPOSABLE POWDER FREE VINYL EXAM GLOVE, manufactured by Full Synergy Medical Products, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Abbreviated 510(k) pathway after a 57-day FDA review.

K113710 · Full Synergy Medical Products, Inc. · General Hospital
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Feb 2012
Decision
57d
Days
Class 1
Risk

K113710 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Full Synergy Medical Products, Inc. (Rancho Cuamonga, US). The FDA issued a Cleared decision on February 14, 2012 after a review of 57 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.

FDA 510(k) Submission Details - K113710

510(k) Number K113710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2011
Decision Date February 14, 2012
Days to Decision 57 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Standards-based clearance path.

LYZ Device Classification - Class 1, General Controls

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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 - LYZ Vinyl Patient Examination Glove

All 741
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K113710.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K120358 · Hongxin Plastic Products Co., Ltd. · Mar 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR
K113750 · Full Synergy Medical Products, Inc. · Mar 2012
DISPOSABLE VINYL EXAM GLOVE, POWDER FREE
K113797 · Full Synergy Medical Products, Inc. · Mar 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
K113722 · Full Synergy Medical Products, Inc. · Feb 2012
SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL
K112743 · Clean Medical Manfacturing Co;Ltd · Dec 2011
PATIENT EXAMINATION GLOVE
K113193 · Suqian Ruijang Medical Supplies Co., Ltd. · Dec 2011
K113710 · DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
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