(191 days)
The Disposable Surgical Face 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 proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The blue colorant is polypropylene (PP) master batch.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of 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 device.
This document describes the premarket notification (510(k)) for a Disposable Surgical Face Mask, and as such, it does not detail a study involving AI or human reader performance for diagnostic purposes. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.
Therefore, many of the requested criteria related to AI/human reader studies, expert ground truth, adjudication, and large-scale data sets for training/testing are not applicable to this type of device and submission.
However, I can provide the information that is available in the document regarding the acceptance criteria and the study that proves the device meets them, primarily focusing on its physical and biological performance characteristics.
Acceptance Criteria and Device Performance (for a Disposable Surgical Face Mask)
The acceptance criteria for this medical device are based on demonstrating that the proposed Disposable Surgical Face Mask is substantially equivalent to a legally marketed predicate device (K133070 Surgical Face Mask). This is primarily achieved through non-clinical testing against established industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ASTM F2100-11 for Level 2 classification, MIL-M-36945C, 16 CFR 1610, and ISO 10993 standards for biocompatibility. The reported device performance is the result of the non-clinical tests conducted on the proposed device.
| ITEM | Acceptance Criteria (ASTM F2100 Level 2 / Other Standard) | Reported Device Performance (Proposed Device) | Remark (vs. Predicate) |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862-13) | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | SE (Substantially Equivalent) |
| Particulate Filtration Efficiency (ASTM F2299) | $\ge$ 98% | 98.46% | SE |
| Bacterial Filtration Efficiency (ASTM F2101) | $\ge$ 98% | 98.7% | SE |
| Differential Pressure (Delta P) (MIL-M-36954C) |
§ 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.