(208 days)
The IFM Surgical Mask Model SM3 is 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The IFM Surgical Mask Model SM3 is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, melt-blown, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene melt-spunbond, white). Each mask contains ear loops to secure the mask over the user's mouth and nose and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
This device is not made with natural rubber latex.
The document is a 510(k) Premarket Notification for the IFM Surgical Mask Model SM3. It asserts the substantial equivalence of the subject device to a predicate device, the 3M™ High Fluid-Resistant Procedure Mask (K191355, Model Number 1840).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are generally aligned with ASTM F2100 Level 3 performance standards, which are demonstrated through specific test methods.
| Test Parameter / Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance (IFM Surgical Mask Model SM3) | Predicate Device Performance (3M™ High Fluid-Resistant Procedure Mask, Model 1840) | Comparison |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥98% as per ASTM F2101 | ≥98% as per ASTM F2101 | Equal to predicate (meets or exceeds) |
| Particulate Filtration Efficiency (PFE) | ≥98% @ 0.1 micron as per ASTM F2299 | ≥98% @ 0.1 micron as per ASTM F2299 | Equal to predicate (meets or exceeds) |
| Fluid Resistance | 160 mm Hg as per ASTM F1862 | 160 mm Hg as per ASTM F1862 | Equal to predicate (meets or exceeds) |
| Differential Pressure (Delta-P) |
§ 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.