(110 days)
The Disposable Surgical Face Mask is 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 a single use, disposable device(s), provided sterile and non-sterile.
The Disposable Surgical Face Masks are composed of mask body, nose clip and ear loop. The mask is composed of three layers: the inner and outer layers are made of spun-bond nonwoven fabric, and the middle layer is made of melt blown non-woven fabric. The nose clip is made of polyethylene and iron material, ear loop is made of nylon and spandex material. The size of the disposable surgical mask is 17.5*9.5cm with tolerance±5%cm, the length of the ear loop is ≥ 10.0cm. 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 sterile and is intended to be single use, disposable devices.
This is a 510(k) premarket notification for a Disposable Surgical Face Mask, which is a Class II medical device. The document summarizes the performance testing and substantial equivalence to a predicate device.
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:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Functional Tests | ASTM F2100 Level 3 Requirements | |||
| Fluid Resistance (ASTM F1862) | To demonstrate the functionality of the subject device. | 29 out of 32 pass at 160 mmHg for Level 3 | 32 out of 32 per lot pass at 160 mmHg (3 non-consecutive lots tested for sterile and non-sterile) | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate the functionality of the subject device. | ≥ 98% | Lot1: 99.41% (before sterile), 99.50% (sterile), 99.44% (after aging) | |
| Lot2: 99.36% (before sterile), 99.26% (sterile), 99.18% (after aging) | ||||
| Lot3: 99.36% (before sterile), 99.29% (sterile), 99.27% (after aging) | PASS | |||
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate the functionality of the subject device. | ≥ 98% | Lot1: 99.77% (before sterile), 99.79% (sterile), 99.74% (after aging) | |
| Lot2: 99.80% (before sterile), 99.83% (sterile), 99.77% (after aging) | ||||
| Lot3: 99.80% (before sterile), 99.78% (sterile), 99.76% (after aging) | PASS | |||
| Differential Pressure (EN 14683) | To demonstrate the functionality of the subject device. |
§ 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.