Cleared Abbreviated

K113790 - DISPOSABLE VINYL EXAM GLOVE, POWDERED

K113790 is an FDA 510(k) clearance for DISPOSABLE 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 74-day FDA review.

K113790 · Full Synergy Medical Products, Inc. · General Hospital
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Mar 2012
Decision
74d
Days
Class 1
Risk

K113790 is an FDA 510(k) clearance for the DISPOSABLE VINYL EXAM GLOVE, POWDERED. 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 6, 2012 after a review of 74 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 - K113790

510(k) Number K113790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2011
Decision Date March 06, 2012
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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 K113790.
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
K120190 · Rich Mountain Medical Products, Inc. · Apr 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K110536 · Zibo Tengyue Plastic Products Co., Ltd. · Mar 2012
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
K113749 · 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 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
K113790 · DISPOSABLE VINYL EXAM GLOVE, POWDERED
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