(112 days)
The HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Surgical Mask family is intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
Respirator consisting of nonwoven inner facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer and is held in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece
The provided text is a 510(k) Summary for a medical device (HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Surgical Mask family). It describes the device, its intended use, and its performance against pre-defined acceptance criteria through non-clinical testing. It does not involve any clinical studies, expert-based ground truth, or MRMC comparative effectiveness studies as it's a device clearance for a respirator mask, not an AI/software-based medical device.
Therefore, many of the requested elements are "Not Applicable" (NA) for this type of submission.
Here's the information extracted from the text:
1. A table of acceptance criteria and the reported device performance:
| Performance Characteristic | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Filtration Efficiency | TEB-APR-STP-0059 | Minimum efficiency for each filter of ≥95% (≤5% penetration) | Pass |
| Breathability | TEB-APR-STP-0007 and TEB-APR-STP-0003 | Not exceeding 35mmH2O for TEB-APR-STP-0007, Not exceeding 25 mmH2O for TEB-APR-STP-0003 | Pass |
| Fluid Resistance (120mmHg) | ASTM F1862 | Pass at 120mmHg | Pass |
| Fluid Resistance (160mmHg) | ASTM F1862 | Pass at 160mmHg | Pass |
| Flammability | 16 CFR 1610 | Class I Normal Flammability | Pass |
| Biocompatibility (Non-cytotoxic) | ISO 10993-5 L929 MEM Elution Test |
§ 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.