(184 days)
Jian Yu surgical mask is intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The JianYu surgical mask is a single use, disposable device provided non-sterile.
The JianYu surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (spunbond polypropylene, blue), filter layer (meltblown polypropylene, white), and inner layer (spunbond polypropylene, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical mask is a single use, disposable device, provided non-sterile.
The manufacturer, Jiangsu JianYu Health Medical Co., Ltd., submitted a 510(k) premarket notification (K201754) for their JianYu Surgical Mask. The device is classified as a Class II surgical apparel under regulation 21 CFR 878.4040. The predicate device is the "Surgical Face Mask (EL30000)" cleared under K160269.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the JianYu Surgical Mask are based on the ASTM F2100-19 Level 3 standard for medical face mask performance. The reported performance of the device is compared against these criteria, as well as against the predicate device (K160269).
| Performance Metric | Acceptance Criteria (ASTM F2100-19 Level 3) | Reported Device Performance (JianYu Surgical Mask) | Predicate Device (K160269) Performance | Comparison to Predicate |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥98% (ASTM F2101) | Passed at ≥99.9% (ASTM F2101) | Passed at ≥99% (ASTM F2101) | Same |
| 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.