Cleared Abbreviated

K113750 - DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR

K113750 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 75-day FDA review.

K113750 · Full Synergy Medical Products, Inc. · General Hospital
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Mar 2012
Decision
75d
Days
Class 1
Risk

K113750 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE 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 March 5, 2012 after a review of 75 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 - K113750

510(k) Number K113750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2011
Decision Date March 05, 2012
Days to Decision 75 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
54d faster than avg
Panel avg: 129d · This submission: 75d
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 K113750.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
K113749 · Full Synergy Medical Products, Inc. · Mar 2012
DISPOSABLE VINYL EXAM GLOVE, POWDERED
K113790 · Full Synergy Medical Products, Inc. · Mar 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K120358 · Hongxin Plastic Products Co., Ltd. · Mar 2012
DISPOSABLE VINYL EXAM GLOVE, POWDER FREE
K113797 · Full Synergy Medical Products, Inc. · Mar 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
K113710 · Full Synergy Medical Products, Inc. · Feb 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
K113722 · Full Synergy Medical Products, Inc. · Feb 2012
K113750 · DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR
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