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ComPel Surgical gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown.

Surgical gowns may provide different levels of protection dependent upon the fabric materials used and the placement of such materials in the final design of the gown.

When processed according to instructions, ComPel Surgical gowns will function and perform as a surgical gown. The ComPel Surgical gowns are reusable through 75 wash, dry, and sterilization cycles. The gowns are manufactured and distributed as non-sterile surgical gowns that are intended to be processed by health care facilities and/or contract sterilization/laundry companies.

ComPel® 'O' Surgical Attire/Gowns. All the components used in ComPel® Surgical Gowns are made from 100% Dacron polyester filaments. ComPel 'O' fabrics are dyed and treated with a fluorocarbon finish. ComPel® 'O' Surgical Gowns will function as surgical attire when processed according to instructions through 75 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed (wash/dried) by health care facilities and/or contract sterilization/laundries companies. ComPel® 'O' Surgical Gowns are intended to be used as surgical attire in an operating theater. The liquid barrier properties will inhibit the migration of liquids across its surface. Per ANSI/AAMI PB70:2003 standard, the 2-ply gowns with the flat felled seam design are classified as a Level 2 Barrier.

This document is a 510(k) premarket notification for surgical gowns and does not contain information about a device that uses AI or machine learning. Therefore, I cannot provide the requested information about acceptance criteria, study details, expert involvement, or AI-specific performance metrics.

The document discusses the physical properties and intended use of ComPel® Surgical Gowns, including:

• Device Name: ComPel® Surgical Gowns
• Intended Use: To be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids.
• Classification: Level 2 Barrier per ANSI/AAMI PB70:2003 standard.
• Durability: Reusable through 75 complete cycles (wash, dry, and sterilization).
• Materials: 100% Dacron® polyester filaments, treated with a fluorocarbon finish.
• Tests Successfully Completed: Suter Hydrostatic Testing, Impact Penetration Testing, Flammability, Durability, Strength, Lint, Toxicity (Cytotoxicity, Primary Skin Irritation), Compatibility with Steam Sterilization.

The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar technological characteristics and is intended for the same use as a device already on the market.

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