(267 days)
Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adult only. The device is disposable and is indicated for single use. The device is not provided sterile
The Dong Hai Xiang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (polypropylene), Inner layer (polypropylene), Middle Layer filter (Polypropylene Melt-blown), Ear-loops (Spandex + Nylon, Ear Loops way for wearing) and Nose piece (a Polyethylene + Galvanized Iron wire nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face). The Dong Hai Xiang Surgical Masks are single use, adult only, disposable device, provided non-sterile.
This document is a 510(k) Summary for the Dong Hai Xiang Surgical Mask, outlining its safety and effectiveness compared to a predicate device. It details performance criteria typical for surgical masks rather than a complex AI-driven medical device. Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for training set, number of experts for ground truth, MRMC studies) are not applicable here.
Here's an analysis based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:
Device: Dong Hai Xiang Surgical Mask
Type: Surgical Apparel (Class II Medical Device)
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test / Acceptance Criteria | Dong Hai Xiang Surgical Mask Performance |
|---|---|
| Fluid Resistance (ASTM F1862-17) | |
| ≥29 of 32 pass at 160 mmHg | Pass (96/96) - 32 samples from each of 3 non-consecutive lots passed at 160 mmHg. |
| Particulate Filtration Efficiency (ASTM F2299-17) | |
| ≥ 98% | Pass (96/96) - 32 samples from each of 3 non-consecutive lots showed ≥ 99.96% efficiency. |
| Bacterial Filtration Efficiency (ASTM F2101-19) | |
| ≥ 98% | Pass (96/96) - 32 samples from each of 3 non-consecutive lots showed ≥ 99.9% efficiency. |
| Differential Pressure (Delta P) (EN 14683:2019, Annex C and ASTM F2100-19) | |
§ 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.