Cleared Traditional

K924051 - KIT PAK I.V. START KIT

K924051 is an FDA 510(k) clearance for KIT PAK I.V. START KIT, manufactured by Kit Pak, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K924051 · Kit Pak, Inc. · General Hospital
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Jun 1993
Decision
314d
Days
Class 1
Risk

K924051 is an FDA 510(k) clearance for the KIT PAK I.V. START KIT. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Kit Pak, Inc. devices

FDA 510(k) Submission Details - K924051

510(k) Number K924051 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received August 12, 1992
Decision Date June 22, 1993
Days to Decision 314 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
185d slower than avg
Panel avg: 129d · This submission: 314d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 709
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K924051.
COMFIT BLUE POWDER FREE EXAMINATION GLOVE
K934813 · Wembley Rubber Products (M) Sdn Bhd · Jan 1994
POWDERFREE NATURAL LATEX GLOVES
K921389 · Arista Latindo Industrial Ltd. P.T · Aug 1993
DIGITEX, DIGITEX HYPOALLERGENIC
K926049 · Mayer Laboratories · Jul 1993
NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED)
K925683 · Arista Latindo Industrial Ltd. P.T · Jun 1993
SOLACE POWDER FREE LATEX EXAMINATION GLOVES
K922551 · Wembley Rubber Products (M) Sdn Bhd · May 1993
ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES
K913766 · Ansell, Inc. · Mar 1993