(94 days)
The Cardinal Health™ Level 3 surgical masks with Anti-Fog Foam Strip are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 3 surgical masks are single use, disposable devices provided non-sterile.
The Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is a four-layer mask constructed of 1 layer of nonwoven polyester/polyethylene blend (inner facing), 1 layer of nonwoven polyolefin melt blown (filter media), 1 layer of nonwoven polyester/polyethylene blend (middle layer), and 1 layer polyolefin spunbond material (outer facing). The four layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The mask is provided with nonwoven polyolefin ties attached by ultrasonic welding. A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The Anti-Fog Foam Strip is intended to minimize fogging.
The provided text describes the acceptance criteria and the study conducted for the Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip (K192374).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Purpose | Acceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%) | Reported Device Performance (Test Results) | Average Performance |
|---|---|---|---|---|
| ASTM F1862 Synthetic Blood | Determine synthetic blood penetration resistance | 160 mmHg | Pass (31/32) | N/A |
| ASTM F2101 BFE | Determine the bacterial filtration efficiency | ≥ 98% | Pass (32/32) | 99.7% |
| ASTM F2299 PFE at 0.1 micron | Determine sub-micron particulate filtration efficiency | ≥ 98% | Pass (32/32) | 99.2% |
| Mil-M-36954C Delta P | Determine breathing resistance or differential pressure |
§ 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.