(154 days)
The Disposable Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Disposable Surgical Mask is composed of mask body, nose clip and ear loop. The body of the mask is composed of three layers: the inner and outer layers are made of Spun-bond polypropylene, and the middle layer is made of melt blown non-woven fabric, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex.
The size of the disposable surgical mask is 17.5*9.5cm with tolerance±5% cm, the length of the ear loop is 16cm, and the length of the nose clip should no less than 8.0cm.
The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with non-sterile and is intended to be single use, disposable devices.
The provided document is a 510(k) summary for a Disposable Surgical Mask (K201893). This type of regulatory submission demonstrates substantial equivalence to a predicate device based on non-clinical performance data. It does not involve AI or complex medical imaging, and therefore, many of the requested criteria (like ground truth establishment by experts, MRMC studies, training set details, or sample size for test sets in an AI context) are not applicable to this document.
However, I can extract and present the relevant "acceptance criteria" and "device performance" in a structured way, based on the provided tables.
Acceptance Criteria and Reported Device Performance for Disposable Surgical Mask (K201893)
The study proves the device meets the acceptance criteria through a series of non-clinical performance tests designed to show equivalence to a predicate device (K182514).
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (for Level 2 Surgical Mask) | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | ≥ 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.62% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.9% | Pass |
| Differential Pressure (Delta P) (EN 14683 Annex C) |
§ 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.