Cleared Traditional

K946010 - KAO YING

K946010 is an FDA 510(k) clearance for KAO YING, manufactured by Kao Ying Industrial Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K946010 · Kao Ying Industrial Co., Ltd. · General Hospital
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Mar 1995
Decision
88d
Days
Class 1
Risk

K946010 is an FDA 510(k) clearance for the KAO YING. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Kao Ying Industrial Co., Ltd. (Reston, US). The FDA issued a Cleared decision on March 7, 1995 after a review of 88 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.

View all Kao Ying Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K946010

510(k) Number K946010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1994
Decision Date March 07, 1995
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
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 595
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K946010.
ARISTA VINYL EXAMINATION GLOVES
K954153 · Arista Latindo Industrial Ltd. P.T · Jan 1996
TRIFLEX STERILE SYNTHETIC EXAMINATION GLOVES
K952786 · Baxter Healthcare Corp · Jul 1995
TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES
K944873 · Baxter Healthcare Corp · Mar 1995
TRU-TOUCH MEDICAL GLOVES
K944183 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995
POWDER FREE MEDICAL GLOVE
K944182 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1994
SYNTHETIC MEDICAL GLOVES
K944184 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1994