(501 days)
"Skypro, SP02 Mask (Level 3)" is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended for infection control practices to reduce the potential exposure of the wearer to blood and body fluids. It is a non-sterile, single-use, and disposable device.
"Skypro, SP02 Mask (Level 3)" is a flat-pleated surgical or procedure mask. It is composed of 4-layer spunbond/meltblown polypropylene fabrics, elastic earloops or ties, and a moldable nose clip.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Skypro, SP02 Mask (Level 3)
Product Code: FXX
Regulation Name: Surgical apparel
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Test: | To determine if the mask may cause adverse biological reactions. | ||
| Cytotoxicity Test (MEM Elution) | To determine if the mask may cause cytotoxic effects. | Non-cytotoxic | Non-cytotoxic |
| Sensitization Test (Kligman Max) | To determine if the mask may cause skin sensitization. | Non-sensitizing | Non-sensitizing |
| Primary Skin Irritation Test | To determine if the mask may cause skin irritation. | Non-irritating | Non-irritating |
| Fluid Resistance Test | To determine the capability of mask to resist the penetration of fluids. | Pass @ 160 mmHg | Pass |
| Particle Filtration Efficiency | To measure the filtration efficiency of mask for particulates. | ≥ 98% | 98.59% |
| Bacterial Filtration Efficiency | To measure the filtration efficiency of mask for bacteria. | ≥ 98% | 99.24% |
| Differential Pressure (Delta P) | To measure how easily air is passed, an indicator of air permeability or breathability. |
§ 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.