(125 days)
This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
The Medical Surgical Mask is flat style mask, model MP002-5 utilizing tie-on and model MP002-6 utilizing ear Loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The Medical Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of polypropylene melt-blown. The color of the outer layer is blue (colorant: Copper phthalocyanine/ CAS number: 147-14-8) The models of mask are ear loops and tie-on, masks are held in place over the users' mouth and nose by two high elastic spandex ear loops or bands welded to the face mask. The nose clip contained in the Medical Surgical Mask is in the layers of face mask to allow the user to fit the mask around their nose, which is made of plastic environmental protection line. The Medical Surgical Mask are sold non-sterile and are intended to be single use, disposable device. The dimension of the tie-on band (Model: MP002-5) is 25cm±2cm1cm±0.2cm (LW), and the dimension of the ear loop (Model: MP002-6) is 17cm±0.5cm0.4cm(LW). What's more, the dimension of the nose clip (Model: MP002-5, MP002-6) is 90mm2.5mm 0.45mm (LWH).
This document is a 510(k) summary for a Medical Surgical Mask (Models: MP002-5, MP002-6). The acceptance criteria and performance data provided relate to the physical and performance characteristics of the mask itself, rather than a diagnostic device with an AI algorithm. Therefore, many of the requested points regarding AI model evaluation (like sample size for test/training sets, expert consensus, MRMC studies, standalone performance) are not applicable to this submission.
Here is the information that can be extracted from the provided document, tailored to the type of device (a surgical mask):
1. A table of acceptance criteria and the reported device performance
The document compares the subject device to a predicate device and also lists specific performance test results against established standards.
| Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) | Test Method / Standard | Verdict for Subject Device |
|---|---|---|---|
| Fluid Resistance Performance | ASTM F1862 | ||
| 160 mmHg | 160 mmHg | Identical / Pass | |
| Particulate Filtration Efficiency | ASTM F2299-03 | ||
| 99.9% | ≥98% | Identical (Note 2) / Pass | |
| Bacterial Filtration Efficiency | ASTM F2101-14 | ||
| >99.9% | >99.9% | Identical / Pass | |
| Differential Pressure | EN 14683: 2019, Annex C | ||
| Pass at 2.7 mmH2O/cm² |
§ 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.