(150 days)
The Private Stock Labs Surgical Face Mask is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. Private Stock Labs Surgical 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.
PRIVATE STOCK LABS Surgical Face Mask is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Surgical Face Mask is manufactured with three layers, of which the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with latex materials, but are made of spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of malleable polyethylene wire. The surgical mask will be provided in green of outside and white of inside. PRIVATE STOCK LABS Surgical Face Mask is provided non-sterile and for single use.
This document describes the non-clinical testing performed for the Private Stock Labs Surgical Face Mask (K211425) to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Result for 3 Lots) |
|---|---|---|---|
| Fluid Resistance ASTM F1862 | Evaluate Personal Protective Equipment against fluid penetration, simulating arterial spray. | 29 out of 32 pass at 120mmHg | Lot 1: 32 out of 32 pass at 120mmHg |
| Lot 2: 32 out of 32 pass at 120mmHg | |||
| Lot 3: 32 out of 32 pass at 120mmHg | |||
| Particulate Filtration Efficiency ASTM F2299 | Evaluate the non-viable particle filtration efficiency. | ≥ 98% | Lot 1: 99.9% (32 out of 32 pass) |
| Lot 2: 99.9% (32 out of 32 pass) | |||
| Lot 3: 99.9% (32 out of 32 pass) | |||
| Bacterial Filtration Efficiency ASTM F2101 | Determine the bacterial filtration efficiency. | ≥98% | Lot 1: 99.9% |
| Lot 2: 99.9% | |||
| Lot 3: 99.9% | |||
| Differential Pressure (Delta-P) MIL-M-36954C | Ensure the pressure drop is not too great for user breathing. |
§ 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.