(269 days)
The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are 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 of the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are single use, disposable device(s), provided non-sterile.
The subject devices are ASTM F2100 Level 1 (yellow in color) Procedure Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Procedure Masks are provided with earloops and a malleable nosepiece. The ASTM F2100 Level 1 Procedure Masks that are the subject of this submission are not provided with a fog-free foam or visor. These masks are single use, disposable devices, provided non-sterile.
The provided text describes a 510(k) premarket notification for two medical masks, HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867) and HALYARD* Level 1 Procedure Mask (48388). This document is a regulatory filing demonstrating "substantial equivalence" to a legally marketed predicate device, the Kimberly-Clark KC100 Face Masks (K110455).
The information provided does not pertain to an AI/ML-driven device or a comparative effectiveness study involving human readers with and without AI assistance. Instead, it details the performance characteristics and safety of physical medical masks based on standardized non-clinical tests. Therefore, many of the requested criteria regarding AI device studies cannot be answered from this document.
However, I can extract information related to the acceptance criteria and the non-clinical study performed for these masks.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document provides a "Technological Characteristics Comparison Table" and a "Summary of Non-Clinical Testing." These tables effectively outline the acceptance criteria (as defined by the predicate device's performance and relevant ASTM/ISO standards) and the results for the subject devices.
| Test / Characteristic | Acceptance Criteria (Predicate / Standard) | Reported Device Performance (Subject Device) |
|---|---|---|
| FDA Product Code | FXX | FXX |
| FDA Classification | Class II | Class II |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 |
| Common Name | Surgical Mask | Surgical Mask |
| Indications for Use | Protection from transfer of microorganisms, body fluids, and particulate material; infection control to reduce potential exposure to blood and body fluids. Single use, disposable, non-sterile. | Protection from transfer of microorganisms, body fluids, and particulate material; infection control to reduce potential exposure to blood and body fluids. Single use, disposable, non-sterile. |
| Over-the-Counter / Prescription | OTC | OTC |
| Number of Layers | 3 | 3 |
| Color | Yellow, blue, green, white, lavender | Yellow |
| Style | Pleated with earloops | Pleated with earloops |
| Outer Layer | Spunbond polypropylene | Spunbond polypropylene |
| Middle Layer | Meltblown polypropylene | Meltblown polypropylene |
| Inner Layer | Polyethylene/polyester | Subject 25867: Polyethylene/polyester; Subject 48388: Spunbond polypropylene |
| Bindings | Spunbond polypropylene or polyester spunlace | Subject 25867: Polyester spunlace; Subject 48388: Spunbond polypropylene |
| Earloop | Polyester/lycra | Polyester/lycra |
| Nose wire | Aluminum or polyethylene coated steel | Polyethylene coated steel |
| Mask Dimension Length | 6.875" ± 0.125" | 6.875" ± 0.125" |
| Mask Dimension Width (Flat) | 3.625" +/- 0.125" | 3.625" +/- 0.125" |
| ASTM F2100 Level | 1 | 1 |
| EN 14683 | Not explicitly stated for predicate in comparison table, but test result provided for subject. | Yes (Pass for 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.