(418 days)
The Dukal Level 1 Pediatric Face Masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. Recommended ages are 4-12. The face mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions in situations where transfer of microorganisms, body fluids, and particulates can occur. The face masks are recommended for use in a healthcare setting with appropriate adult supervision. The Dukal Level 1 Pediatric Face Masks are single use, disposable devices that are provided non-sterile.
Pediatric face masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. The mask is available in the following product sizes: Regular Size (14.5x9cm) and Extra Small Size (12.5x8cm). The Dukal Level 1 Pediatric Face Mask (both sizes) are composed of three layers of materials and pleated to form the mask. The inner layer is composed of Polypropylene (Spunbond), the middle layer is Polypropylene (Meltblown) filter material, and the outer layer is polypropylene (Spunbond). The masks (both sizes) are held in place on wearer with knitted polyester/spandex elastic ear loop and contain a malleable aluminum nosepiece strip. The masks (both sizes) have decorative patterns, printed with colored inks.
This document describes the performance testing for the Dukal Level 1 Pediatric Face Mask. The device is a medical face mask and the acceptance criteria and performance are based on established standards for such devices.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared to the requirements specified by various test standards, primarily ASTM F2100-19 Level 1 requirements for medical face masks.
| Test Item | Test Standard Methods | Test Requirements | Subject Device Dukal Level 1 Pediatric Face Masks (meets ASTM F2100-19 Level 1 requirements) | Remark |
|---|---|---|---|---|
| Bacterial Filtration Efficiency Performance (BFE) (%) | ASTM F2101 | ≥95% | >99% | Meets requirement |
| Particulate Filtration Efficiency Performance (PFE) (%) | ASTM F2299 | ≥95% | >99% | Meets requirement |
| Differential Pressure (Delta-P) (mm H2O/cm²) | 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.