(140 days)
The Sparta 3-Ply Surgical Disposable Face Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Sparta 3-Ply Surgical Disposable 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, non-sterile, disposable device.
The Sparta 3-Ply Surgical Disposable Face Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the user's face. The mask outward facing layer is blue in color, using color master batch. The device is manufactured with three layers: Outer Layer: Spunbond polypropylene, Middle Layer: Melt Blown polypropylene, Inner Layer: Spunbond polypropylene. The subject device is provided non-sterile and is a single use, disposable device.
The Sparta 3-Ply Surgical Disposable Face Mask is intended to protect both patients and healthcare professionals from the transfer of microorganisms, body fluids, and particulate material. It's designed for single use, non-sterile, and disposable applications in infection control practices. The device was deemed substantially equivalent to the predicate device, Disposable Surgical Mask K202463.
Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Characteristic | Acceptance Criteria (Predicate or Standard) | Reported Device Performance (Subject Device) | Comparison Analysis |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862-13) | Not publically available (implicitly met by predicate) | 96 Passed (3 batches of 32) | Substantially Equivalent |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 99% | ≥98% | Substantially Equivalent |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 0.999 (implicitly 99.9%) | Substantially Equivalent |
| Differential Pressure (Delta P) (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.