(236 days)
The Dukal Corporation Level 3 Surgical Face Masks 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.
Face Masks intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material.
The provided document is a 510(k) summary for the Dukal Corporation Level 3 Surgical Face Masks. This type of document is for regulatory clearance of medical devices, demonstrating substantial equivalence to a predicate device, rather than proving that a device meets particular acceptance criteria through a clinical study. Therefore, much of the requested information about a study is not available in this text, as it describes performance testing results for a medical device (surgical face masks).
However, I can extract the acceptance criteria (defined by ASTM F2100-19 Level 3 requirements for the subject device and ASTM F2100-11 Level 3 requirements for the predicate) and the reported device performance.
Acceptance Criteria and Reported Device Performance
Device: Dukal Corporation Level 3 Surgical Face Masks with Ear Loop and Level 3 Surgical Face Masks with Tie On
| Test | Acceptance Criteria (ASTM F2100 Level 3 Requirements) | Reported Device Performance (Dukal Corporation Level 3 Surgical Face Masks) |
|---|---|---|
| ASTM F2101-Bacterial Filtration Efficiency (BFE) | ≥98% | >99.9% |
| ASTM F2299-Particulate Filtration Efficiency | ≥98% | >99% |
| EN 14683-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.