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Med-Tainer Single Deposit Containers (SDC) are intended for the safe collection and transport of medical sharps. The reusable 10 gallon and 17 gallon containers are to be used in supervised areas of healthcare institutions such as hospitals, clinics, veterinary offices and laboratories.

Device Description

Med-Tainer Single Deposit Container (SDC) is used to collect medical sharps in supervised areas of healthcare facilities. The containers are rotationally molded and made of low density polyethylene. They are available in 17 gallon and 10 gallon sizes and in five colors: red, teal, yellow, blue and green. Med-Tainer SDC is a reusable container intended to be reprocessed up to 780 times. The products are supplied to waste management companies that are responsible for transporting, decanting, decontaminating, and destroying the containers. The accompanying lids vary by purpose. The black transport lid is used during transport of the filled container. The combination of black large lab lid, with an opening to discard sharps, and the black small lab lid, used to slide across the large lab lid when not in use, allows easy disposal of sharps. The color coordinating restrictive lid with a mail box type opening is intended to prevent hand or finger access.

AI/ML Overview

This document describes the Med-Tainer Single Deposit Container (SDC), a device for the safe collection and transport of medical sharps. The bulk of the provided text details various performance tests conducted on the device to prove it meets certain acceptance criteria.

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test Name	Reported Device Performance
Life Span Processing Simulation (per CAN/CSA Z316.6-14 BA.8.3.1) - 780 processing cycles without damage	All containers successfully completed 780 processing simulation cycles without damage.
Life Span Transport Simulation (per CAN/CSA Z316.6-14 BA.8.3.2) - 780 transport cycles without damage	All containers completed transportation without damage.
Leak Resistance Test (per Health Devices, August - September 1993, ECRI, Vol. 22 Nos. 8-9 pgs. 383-384) - No loss of fluid after 24 hours	Passed (containers processed 780 times were filled with water and checked after 24 hours for loss of fluid).
Container Stability Test (per ISO 23907) - Does not topple over on a 15° incline	Passed (containers processed 780 times were filled with material of density 0.20 ± 0.01kg/l and placed on an incline with a minimum angle of 15°, repeated for each side).
Strength of Handles (per ISO 23907) - No breakage or detachment when suspended for an hour with 150% maximum gross mass	Passed (containers processed 780 times were filled with a mass equivalent to 150% of the manufacturer's maximum gross mass, closed, suspended by handles for an hour at 23 ± 5℃, and examined).
Resistance to Damage and Leakage after Dropping (per ISO 23907) - No leakage or loss of integrity after 1-meter drop	Passed (containers processed 780 times, filled with liquid and sharps, closed, and dropped 1 meter on bottom, side wall, and adjacent side wall; inspected for leakage and/or loss of integrity).
Resistance to Damage and Leakage after Dropping (modified) (per ISO 23907) - No leakage or loss of integrity after 1-meter drop with heavier fill	Passed (containers filled with liquid, sharps, glass, and stainless steel (40.1 lbs), closed, and dropped 1 meter on bottom, side wall, and adjacent side wall; inspected for leakage and/or loss of integrity).
Puncture Resistance (per ASTM F2132-01) - Average ≥ 3.4 lbf (15 N), no value

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