(293 days)
The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are single use, disposable device(s), provided non-sterile.
The subject device(s) are ASTM F2100 Level 1 (white in color) Procedure and Surgical Mask(s). The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Mask(s) are provided with earloops. A malleable nosepiece is placed within the bindings. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family will be provided in designs with and without a protective visor. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family are single use, disposable devices, provided non-sterile.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Purpose | Test | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Face Mask Performance | ASTM F2100 | ASTM F2100 Level 1 | Pass |
| Bacterial Filtration Efficiency | ASTM F2101 | ≥95% | Pass |
| Particulate Filtration Efficiency | ASTM F2299 | ≥95% | Pass |
| Differential Pressure | EN 14683 |
§ 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.