(60 days)
The Surgical Face Mask 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 the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
Surgical Face Mask is composed of Nylon and Spandex ear loops, Iron-plastic nose clip, Inner layer Spunbond polypropylene, Middle Melt-blown polypropylene and outer Spun-bond polypropylene. The meltblown polypropylene material acts as the filter that stops microbes from entering or exiting the mask. Surgical Face Masks feature pleats or folds. Three pleats are used to allow the user to expand the mask such that it covers the area from the nose to the chin. The type is ear-loop, where a string-like material is attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document describes the non-clinical testing performed for a Surgical Face Mask (Model: 17.5X9.5CM EAR-LOOP) to demonstrate its substantial equivalence to a legally marketed predicate device. This is not an AI/ML medical device, and therefore, the requested information regarding AI/ML-specific study aspects (like expert ground truth establishment, MRMC studies, training/test set details, etc.) is not applicable to this document.
The document focuses on the physical performance and biocompatibility of the surgical face mask, comparing it to established industry standards for surgical apparel.
Here's the relevant information extracted and presented based on the document:
Device: Surgical Face Mask, Model: 17.5X9.5CM EAR-LOOP
Regulatory Class: Class II
Product Code: FXX
Regulation Number: 21 CFR 878.4040 (Surgical Apparel)
Predicate Device: K203426, Surgical Face Mask (non-sterile)
Study Type: Non-clinical (performance and biocompatibility)
Clinical Test Conclusion: No clinical study was included in this submission.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against ASTM F2100-19 Level 2 performance standards and ISO 10993 for biocompatibility.
| Item | Purpose | Acceptance Criteria (ASTM F2100-19 Level 2) | Reported Device Performance (Result; average performance if provided) |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure | 29 out of 32 pass at 120 mmHg | PASS (Results for individual lots not detailed beyond "PASS" matching the criteria) |
| Particulate Filtration Efficiency (ASTM F2299) | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | ≥ 98% | PASS (Lot1: 99.17%, Lot2: 99.49%, Lot3: 98.90%) |
| Bacterial Filtration Efficiency (ASTM F2101) | Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism | ≥ 98% | PASS (Lot1: 99.87%, Lot2: 99.9%, Lot3: 99.84%) |
| Differential Pressure (Delta P) (EN 14683 Annex C) | Assess the performance of a mask for resistance to air movement through the materials of the face of the mask |
§ 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.