(324 days)
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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.