(276 days)
The Spin Care Disposable Protective Mask is 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, provided non-sterile.
The Spin Care Disposable Protective Mask is a single use multi-layer level 2 surgical mask. It houses a meltblown polypropylene filter between an outer and inner layer of Spunbond polypropylene that covers the nose and mouth of the end user and held in place by a pliable nose piece and ear loops. Contact duration is less than 24 hours.
This document describes the acceptance criteria and performance of the "Spin Care Disposable Protective Mask". Since this is a medical device, the acceptance criteria are based on non-clinical performance tests.
1. Table of Acceptance Criteria and Reported Device Performance
The device is designed to meet the ASTM 2100 Level 2 standard for medical face masks. The table below summarizes the key performance criteria and the results for the Spin Care Disposable Protective Mask, compared to its predicate devices.
| Performance Characteristic | Acceptance Criteria (ASTM 2100 Level 2) | Spin Care Disposable Protective Mask Performance | Primary Predicate (K153496) Performance | Secondary Predicate (K160269) Performance |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 120 mmHg - Pass | 120 mmHg - Pass | 120 mmHg - Pass | 120 mmHg - Pass |
| Particle Filtration Efficiency (ASTM F2299) | ≥ 98% | Average 99.8% - Pass | Average 98.46% - Pass | Average 99.6% - Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Average > 99.9% - Pass | Average 98.7% - Pass | Average > 98% - Pass |
| Flammability Class (16 CFR 1610) | Class I Non-Flammable | Class I Non-Flammable | Class I Non-Flammable | Class I Non-Flammable |
| Delta-P (Differential Pressure) (EN 14683) |
§ 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.