(157 days)
The surgical face 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 face 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(s), provided non-sterile.
Surgical Face Mask is composed of a mask body, a nose clip, and two ear ropes. The mask body of ear loop type has three layers in structure: the inner and outer layers are made of polypropylene non-woven fabrics, and the middle layer is made of polypropylene melt-blown cloth. The component ratio is 24.5% melt blown cloth and 71.5% PP non-woven. The nose clip contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PE. The ear ropes are made of nylon and spandex. This is a single use, disposable device(s), provided non-sterile.
The provided text describes the non-clinical performance testing for a medical device, a Surgical Face Mask (K210015). It does not describe a study involving an algorithm, AI assistance, or human readers, which is implied by several of the questions in the prompt. Therefore, I can only address aspects of the prompt that directly relate to the provided text regarding the performance of the surgical face mask.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
Device: Surgical Face Mask (K210015)
Study Type: Non-clinical Performance Testing (physical and biological properties of the mask)
1. A table of acceptance criteria and the reported device performance
| Item | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance Performance (mmHg) | ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood | At least 29 out of 32 specimens show passing results at 160 mmHg | Total 3 lots 96/96. All samples met the predetermined acceptance criteria. |
| Particulate Filtration Efficiency (%) | ASTM F2299 / F2299M - 03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres | ≥ 98% | 99.6% , total 3 lots 95 out of 96 samples met the predetermined acceptance criteria. |
| Bacterial Filtration Efficiency (%) | ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks | ≥ 98% | >99.9%, total 3 lots 96/96 All samples met the predetermined acceptance criteria. |
| Differential Pressure (Delta-P) (mm H2O/cm2) | ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks |
§ 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.