Cleared Abbreviated

K120746 - DISPOSABLE POWDER FREE VINYL EXAM GLOVES

K120746 is an FDA 510(k) clearance for DISPOSABLE POWDER FREE VINYL EXAM GLOVES, manufactured by Canopus Medical Supply Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Abbreviated 510(k) pathway after a 46-day FDA review.

K120746 · Canopus Medical Supply Co., Ltd. · General Hospital
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Apr 2012
Decision
46d
Days
Class 1
Risk

K120746 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE VINYL EXAM GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Canopus Medical Supply Co., Ltd. (Rowland Highs, US). The FDA issued a Cleared decision on April 27, 2012 after a review of 46 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 Canopus Medical Supply Co., Ltd. devices

FDA 510(k) Submission Details - K120746

510(k) Number K120746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2012
Decision Date April 27, 2012
Days to Decision 46 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
83d faster than avg
Panel avg: 129d · This submission: 46d
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 317
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K120746.
DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR
K120798 · Canopus Medical Supply Co., Ltd. · May 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K112266 · Shandong Zhiyuan Medical Products Co., Ltd. · May 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K113837 · Hebei Changsheng Plastic Products Co., Ltd. · Apr 2012
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