(428 days)
The disposable surgical face mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device, Disposable Surgical Face Mask is a three-layer, flat-folded mask. The mask body is made of 25g/m2 polypropylene (PP) non-woven cloth. The mask contains tie strings or ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Polyurethane and spandex, and tie strings are made of polypropylene nonwoven cloth. The nose clip which is made of Iron-Zinc strip covered by polyethylene terephthalate (PET) covering. The disposable surgical face mask is available in two different specifications: 17.5×9.5cm and 16.5×8.5cm. The device is single use and provided sterile.
The document describes the testing and acceptance criteria for a "Disposable Surgical Face Mask" (K212649). This is a medical device, not an AI/ML device, therefore, many of the requested categories such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "sample size for the training set" are not applicable.
Here's the information extracted and organized as requested, with "N/A" for sections not relevant to a non-AI medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| No | Item | Test Method/Standard | Type | Acceptance Criteria | Reported Performance for Ear Loop Type | Reported Performance for Tie-on Type |
|---|---|---|---|---|---|---|
| 1 | Particulates Filtration Efficiency | ASTM F2299/F2299M-03(2017) | Ear loop | ≥98% | Lot 1: 98.81% | |
| Lot 2: 98.78% | ||||||
| Lot 3: 98.8% | N/A (listed separately below) | |||||
| Tie-on | ≥98% | N/A (listed above) | Lot 1: 98.82% | |||
| Lot 2: 98.78% | ||||||
| Lot 3: 98.79% | ||||||
| 2 | Bacterial Filtration Efficiency | ASTM F2101-19 | Ear loop | ≥98% | Lot 1: 99.9% | |
| Lot 2: 99.91% | ||||||
| Lot 3: 99.91% | N/A (listed separately below) | |||||
| Tie-on | ≥98% | N/A (listed above) | Lot 1: 99.91% | |||
| Lot 2: 99.9% | ||||||
| Lot 3: 99.91% | ||||||
| 3 | Fluid Resistance | ASTM F1862/F1826M-17 | Ear loop | 120 mmHg | Lot 1: No penetration at 120 mmHg | |
| Lot 2: No penetration at 120 mmHg | ||||||
| Lot 3: No penetration at 120 mmHg | N/A (listed separately below) | |||||
| Tie-on | 120 mmHg | N/A (listed above) | Lot 1: No penetration at 120 mmHg | |||
| Lot 2: No penetration at 120 mmHg | ||||||
| Lot 3: No penetration at 120 mmHg | ||||||
| 4 | Differential Pressure | EN 14683:2019 | Ear loop | △P |
§ 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.