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510(k) Data Aggregation
(58 days)
The TE Gown is intended to provide the wearer an increased level of blood and other body fluid protection during certain surgical procedures that result in excessive blood exposures by providing total encapsulation.
The COOL-ZONE System is either a gown or hood that are similar to the Kappler Pro/Vent Surgical Gown which was the subject of Premarket Notification #K932694. The fabric in the COOL-20NE gown and hood is identical to the fabric in the Pro/Vent Surgical Gown. The Pro/Vent TE Gown and Hood are constructed from the same fabric as the predicate device. The design of the gown differs in that the gament provides totally encapsulated protection to the wearer. Total encapsulation means total coverage of the entire upper body, thus providing greater protection than conventional surgical apparel.. The TE Gown utilizes a mylar face shield for visibility. A zipper is located in the back of the garment. The TE Hood provides the same level of face and head protection, but does not extend down as far on the body. It will typically be worn with another surgical gown.
This document is a 510(k) Summary for a medical device (surgical gown/hood) and does not describe an AI/ML powered device. Therefore, most of the requested information regarding AI-specific evaluation criteria, such as "Multi Reader Multi Case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only) performance," "sample size for the training set," or "adjudication method for the test set," is not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device based on material composition, design, and non-clinical performance characteristics.
Here's an attempt to extract relevant information given the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the properties of the predicate device (Kappler Pro/Vent Surgical Gown). The device ("PRO/VENT TE") is considered to meet acceptance criteria if its characteristics are "identical" or equivalent to the predicate.
| CHARACTERISTIC | Acceptance Criteria (Predicate: PRO/VENT GOWN) | Reported Device Performance (PRO/VENT TE) |
|---|---|---|
| Material Composition | 100% Polypropylene | 100% Polypropylene |
| Fabric Configuration | Trilaminate | Trilaminate |
| Barrier Layer | Microporous Film | Microporous Film |
| Composite Weight | 2.1 oz/square yard | 2.1 oz/square yard |
| Hydrostatic Head | 43 inches | 43 inches |
| Bacterial Filtration | 99.9% | 99.9% |
| Moisture Vapor Transmission Rate | 1385 g/sqm/24hr | 1385 g/sqm/24hr |
| Flammability | Class 1 | Class 1 |
| Synthetic Blood/Viral Resistance | Pass | Pass |
| Sterility Assurance Level (SAL) | 10⁻⁶ (typical for medical devices) | 10⁻⁶ |
| Ethylene Oxide Residues |
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