Cleared Traditional

K113722 - DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR

K113722 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 Traditional 510(k) pathway after a 57-day FDA review.

K113722 · Full Synergy Medical Products, Inc. · General Hospital
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Feb 2012
Decision
57d
Days
Class 1
Risk

K113722 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K113722

510(k) Number K113722 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 Traditional
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
Predicate-based equivalence.

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 K113722.
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, YELLOW COLOR
K113710 · 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
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
K112610 · Inpro Technology Device Factory · Dec 2011
K113722 · DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
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