(134 days)
The surgical mask is intended to be worn to protect both the patient and healthcare personnel 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. This is a single-use, disposable device, provided non-sterile.
The surgical mask is a three-layer flat-pleated mask made of nonwoven polypropylene materials. The inner layer (white color) and the outer layer (blue color) are made of spunbonded polypropylene to provide comfort and breathability; the middle filtration layer is made of melt-blown polypropylene. The three layers are bonded together sonically along the four edges with the inner layer slightly folded over the outer layer along the long edges.
The mask is fitted to cover the wearer's nose and mouth with ear-loops. The ear-loops are made of knitted polyester/ elastane. They are welded to the mask. The materials do not contain natural rubber latex.
A malleable polyethylene laminated aluminum nosepiece is placed between the layers along the top edge of the mask for extra comfort and fit around the wearer's nose.
The surgical mask is intended to be a single-use disposable device, provided non-sterile.
The provided text is a 510(k) Summary for a Surgical Mask, specifically K210524 from Changzhou Holymed Products Co., Ltd. It details the device, its intended use, comparison to a predicate device, and performance testing to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the performance testing is summarized in Table 2: Non-Clinical Performance Testing Table on page 6.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Determine the ability of the mask's material to resist penetration of blood and body fluids. | Pass/fail basis at any of three velocities corresponding to the range of human blood pressure: | |
| Level 1 – 80 mmHg | |||
| Level 2 – 120 mmHg | |||
| Level 3 - 160 mmHg | Level 3 | ||
| Passed at 160 mmHg. | |||
| All 3 lots tested passed with no synthetic blood penetration observed at 160 mmHg, under the conditions of the test. | |||
| Particulate Filtration Efficiency (ASTM F2299) | Determine the ability of the mask's material to prevent passage of aerosolized submicron particulates. | Pass/fail basis: | |
| Level 1 – 95% | |||
| Level 2 – 98% | |||
| Level 3 – 98% | Level 3 | ||
| Passed at > 99.9% | |||
| Average Filtration Efficiency: | |||
| AMSB-LOT202010007: >99.979% | |||
| AMSB-LOT202011002: >99.9814% | |||
| AMSB-LOT202011005: >99.984% | |||
| Bacterial Filtration Efficiency (ASTM F2101-19) | Determine the ability of the mask's material to prevent passage of aerosolized bacteria. | Pass/fail basis: | |
| Level 1 - 95% | |||
| Level 2 – 98% | |||
| Level 3 – 98% | Level 3 | ||
| Passed at ≥ 99.9% | |||
| All samples tested passed with a filtration efficiency percentage of at least 99.9%, under the conditions of the test. | |||
| Differential Pressure (ASTM F2101-19, same as BFE) | Determine the resistance of the surgical facemask to air flowing through the mask. | Pass/fail basis: | |
| Level 1 – |
§ 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.