(87 days)
The Altor Safety 4-Ply Surgical Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 4-Ply Surgical 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 Altor Safety 4-Ply Surgical Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The mask outward facing layer is blue in color, using color master batch. The device is manufactured with 4 layers: 2-Outer Facing Layers: Spunbond nonwoven polypropylene (Blue), Middle Layer: Melt Blown nonwoven polypropylene (White) and Inner Layer: Spunbond nonwoven polypropylene (White). Other Materials used include the Ear loops which are made from Spandex / Nylon. The subject device is provided non-sterile and is a single use, disposable device.
This document is a 510(k) summary for a surgical mask (Altor Safety 4-Ply Surgical Mask, Model: 62232). It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than a study involving human or AI performance. Therefore, many of the requested elements for a study proving a device meets acceptance criteria, particularly for AI/human reader performance, are not applicable to this document.
However, I can extract the acceptance criteria (pass criteria) and reported device performance for the physical and biological characteristics of the surgical mask, as detailed in the non-clinical performance testing section.
Here's a breakdown of the requested information based solely on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria (Pass Criteria) | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM F2101-19 (Bacterial Filtration Efficiency - BFE) | Evaluate Bacterial filtration efficiency (%) | ≥98% | 3 lots tested with total 96 samples, 94/96 Passed at ≥98% /Pass (Note: Listed as 99.60% in Table 1) |
| EN 14683: 2019, Annex C (Differential Pressure - Delta-P) | Evaluate Differential pressure (Delta-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.