(217 days)
The surgical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided nonsterile.
The Surgical Face Masks (Ear loops and Tie-on) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polypropylene/polyester). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white or blue and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.
The provided document describes the acceptance criteria and performance of Surgical Face Masks (Ear loops and Tie-on) as part of a 510(k) premarket notification. The study aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove device meets an absolute acceptance criteria.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" but rather "performance requirements" as outlined by recognized standards (ASTM F2100-11 for various levels) and then reports the device's performance against these requirements. It also compares the proposed device's performance to predicate devices.
Acceptance Criteria (Performance Requirements from ASTM F2100-11) and Reported Device Performance
| Test | Level 1 Acceptance Criteria (Per ASTM F2100-11) | Level 1 Reported Device Performance | Level 2 Acceptance Criteria (Per ASTM F2100-11) | Level 2 Reported Device Performance | Level 3 Acceptance Criteria (Per ASTM F2100-11) | Level 3 Reported Device Performance |
|---|---|---|---|---|---|---|
| ASTM F1862 (Fluid Resistance) | Pass at 80 mmHg | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Pass at 160 mmHg |
| ASTM F2299 (Particulate Filtration Efficiency) | ≥ 95% | Pass at 99.6% | ≥ 95% | Pass at 99.6% | ≥ 98% | Pass at 99.7% |
| ASTM F2101 (Bacterial Filtration Efficiency) | ≥ 95% | Pass at >98% | ≥ 95% | Pass at >98% | ≥ 98% | Pass at >99% |
| MIL-M36945C (Differential Pressure) |
§ 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.