Cleared Traditional

K940035 - KIT,I.V. START

K940035 is an FDA 510(k) clearance for KIT, manufactured by Mason-Keller Corp.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K940035 · Mason-Keller Corp. · General Hospital
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Jun 1994
Decision
150d
Days
Class 1
Risk

K940035 is an FDA 510(k) clearance for the KIT,I.V. START. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Mason-Keller Corp. (Roseland, US). The FDA issued a Cleared decision on June 3, 1994 after a review of 150 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Mason-Keller Corp. devices

FDA 510(k) Submission Details - K940035

510(k) Number K940035 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received January 04, 1994
Decision Date June 03, 1994
Days to Decision 150 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
21d slower than avg
Panel avg: 129d · This submission: 150d
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 K940035.
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
VINYL EXAMINATION GLOVES (NON STERILE)
K934536 · Arista Latindo Industrial Ltd. P.T · Jun 1994
SENSICARE POWDER FREE MEDICAL GLOVE
K925244 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1993
DERMACARE SYNTHETIC MEDICAL GLOVE
K914763 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
SENSICARE SYNTHETIC MEDICAL GLOVES
K915478 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992