Cleared Abbreviated

K120798 - DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR

K120798 is an FDA 510(k) clearance for DISPOSABLE POWER FREE VINYL EXAM GLOVE, 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 60-day FDA review.

K120798 · Canopus Medical Supply Co., Ltd. · General Hospital
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May 2012
Decision
60d
Days
Class 1
Risk

K120798 is an FDA 510(k) clearance for the DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR. 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 May 14, 2012 after a review of 60 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 - K120798

510(k) Number K120798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2012
Decision Date May 14, 2012
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 K120798.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K120797 · Shandong Shouguang Kingliyuan Medical Apparatus & · Jul 2012
POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES
K120584 · Wealth on (Jiangsu) Co., Ltd. · Jul 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
K113194 · Suqian Ruijang Medical Supplies 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 GLOVES
K120746 · Canopus Medical Supply Co., Ltd. · Apr 2012