(69 days)
The product is intended to be worn to protect both the patients and healthcare personnel from transfer of microorganisms, body fluids and particulate materials. These masks are intended for adult 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/sterile.
The proposed devices are three-layer, flat pleated masks. It has two design styles, i.e. earloop and tie-on. Each mask is composed of a mask body, a nose piece, two ear loops or four tie tapes. The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric. The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four tie tapes welded to the mask body. The elastic ear loops are knitted elastic loops (made of nylon and spandex), and the tie tapes are made of polypropylene nonwoven fabric. The nose piece is enclosed between the layers of face mask to allow the user to fit the face mask around their nose, which is an iron wire with polypropylene covering. The proposed devices can simultaneously meet the requirements for the performance class of level 2 and level 3 specified in ASTM F2100. Both of the two design styles are available non-sterile. They are intended to be single use, disposable devices.
The provided document is a 510(k) summary for a Surgical Mask (K222335) and does not describe an AI/ML powered medical device. Therefore, the information typically requested regarding acceptance criteria, study details, and ground truth establishment for such devices (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) will not be present.
Instead, the document details the performance testing of the surgical mask against established standards for medical face masks. The acceptance criteria are based on ASTM F2100-19 for performance and ISO 10993 for biocompatibility.
Here's a summary based on the provided text for a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance:
| Test | Purpose | Acceptance Criteria per ASTM F2100-19 (AQL=4.0%) | Reported Device Performance (Sterile earloop mask, 175*95mm) | Reported Device Performance (Non-sterile earloop mask, 175*95mm) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Verify the fluid resistance of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: Pass at 120 mmHg | ||
| Level 3: Pass at 160 mmHg | 96 out of 96 pass at 120 mmHg | |||
| 96 out of 96 pass at 160 mmHg | 96 out of 96 pass at 120 mmHg | |||
| 94 out of 96 pass at 160 mmHg¹ | ||||
| Bacterial filtration efficiency (BFE) (ASTM F2101) | Verify the bacterial filtration efficiency of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: ≥98% | ||
| Level 3: ≥98% | 99.4%~99.7% (Average: 99.6%) | >99.9% (Average: >99.9%) | ||
| Particulate filtration efficiency (PFE) (ASTM F2299) | Verify the particulate filtration efficiency of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: ≥98% | ||
| Level 3: ≥98% | 97.64%~99.11% ² (Average: 98.38%) | 99.88%~>99.9977% (Average: >99.99%) | ||
| Differential pressure (Delta-P) (EN 14683) | Verify the differential pressure of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: |
§ 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.