Cleared Traditional

K935131 - FAMILY FIRST AID KIT (FDA 510(k) Clearance)

Class I General Hospital device.

K935131 · Medical Technologies International, Inc. · General Hospital
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Mar 1994
Decision
146d
Days
Class 1
Risk

K935131 is an FDA 510(k) clearance for the FAMILY FIRST AID KIT. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Medical Technologies International, Inc. (Kent, US). The FDA issued a Cleared decision on March 23, 1994 after a review of 146 days - within the typical 510(k) review window.

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 Medical Technologies International, Inc. devices

Submission Details

510(k) Number K935131 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received October 28, 1993
Decision Date March 23, 1994
Days to Decision 146 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
18d slower than avg
Panel avg: 128d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K935131.
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