(42 days)
The Dukal medical / surgical masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.
Dukal Surgical Masks are pleated 3 - ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% melt blown polypropylene filter. Ear loops are made of soft latex free elastic loops. The nose piece for all Dukal Masks is a malleable aluminum wire. Masks with splash visors have an anti fog treated plastic shield attached to masks. All of the material used in the construction of the Dukal face masks are being used in currently marketed devices (see predicate information)
The provided text describes a 510(k) premarket notification for a non-sterile surgical mask (Dukal Surgical Face Mask, referenced as K070407). However, the information provided focuses primarily on regulatory aspects, device description, and intended use, rather than conducting a detailed study with specific acceptance criteria and performance data in the way a diagnostic AI device would.
Based on the provided text, here's a breakdown regarding acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
For this surgical mask, the "acceptance criteria" are defined by the adherence to a recognized performance standard, specifically ASTM 2100-04. The document states, "Recognized Performance Standard: ASTM 2100-04 Refer to submission for applicable standards."
The document does not explicitly list the quantitative acceptance criteria defined within ASTM 2100-04 or the specific test results showing the device performing against these criteria in a table format within the provided excerpt. It simply refers to the standard as being part of the larger submission.
However, based on general knowledge of ASTM F2100 (which is the standard for Medical Face Mask Materials, often referred to as ASTM 2100-04 in older documents), the acceptance criteria typically cover:
| Performance Metric | Acceptance Criteria (from ASTM F2100 - General Expectations, not explicitly stated in the provided text for this specific device) | Reported Device Performance (Not explicitly detailed in the provided text, only a general assertion of conformance to the standard) |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | Typically >= 95% or >= 98% (depending on level) | Implied to meet relevant level of ASTM 2100-04 |
| Particulate Filtration Efficiency (PFE) | Typically >= 95% or >= 98% (depending on level) | Implied to meet relevant level of ASTM 2100-04 |
| Differential Pressure (Delta P) | Typically |
§ 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.