Cleared Traditional

K950357 - SURVIVAL KIT

K950357 is an FDA 510(k) clearance for SURVIVAL KIT, manufactured by Opportunity Resources, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K950357 · Opportunity Resources, Inc. · General Hospital
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Jun 1995
Decision
147d
Days
Class 1
Risk

K950357 is an FDA 510(k) clearance for the SURVIVAL KIT. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Opportunity Resources, Inc. (Missoula, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 147 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 Opportunity Resources, Inc. devices

FDA 510(k) Submission Details - K950357

510(k) Number K950357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1995
Decision Date June 22, 1995
Days to Decision 147 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: 129d · This submission: 147d
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 K950357.
SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE
K952404 · Aladan Corp. · Jul 1995
CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE
K952367 · Cypress Medical Products, Ltd. · Jul 1995
SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE
K952556 · Aladan Corp. · Jun 1995
ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES
K951839 · Aladan Corp. · Jun 1995
LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC)
K946257 · Siam Sempermed Corp., Ltd. · Jun 1995
COMFIT (PINK)
K943601 · Wembley Rubber Products (M) Sdn Bhd · May 1995