(248 days)
The Single-Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask 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.
Model: M and L, blue color, and Level 3 barrier level as ASTM F2100
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device(s) are meet Level 3 requirements per ASTM F2100.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven fabric, and the middle layer is made of Melt-blown non-woven fabric. The blue colorant is blue masterbatch.
The Single-Use Surgical Mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with Polypropylene fiber.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
There are two models included, Model M and L. The two models share the same indication for use, instruction for use, material used, and structure. The dimension, the model L is bigger than model M.
The provided document is a 510(k) premarket notification for a Single-Use Surgical Mask, not an AI/ML medical device. Therefore, many of the requested criteria regarding AI/ML model acceptance (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical performance testing and biocompatibility testing, along with a comparison of physical characteristics.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of the Test Methodology/Standard | Purpose | Acceptance Criteria (FDA/ASTM F2100 Level 3 Requirements) | Reported Device Performance (Proposed Device K201924) |
|---|---|---|---|
| ASTM F1862 (Fluid Resistance) | Resistance to penetration by synthetic blood | 160 mm Hg | 160 mm Hg |
| ASTM F2299 (Particulate Filtration Efficiency) | Sub-micron particulate filtration efficiency at 0.1 micron | ≥ 98% | ≥ 99.03% |
| ASTM F2101 (Bacterial Filtration Efficiency) | Bacterial Filtration Efficiency | ≥ 98% | ≥ 99.50% |
| MIL-M-36954C (Differential Pressure) | Differential Pressure |
§ 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.