(333 days)
West Tec Procedure and Surgical facemasks are intended to be worn by healthcare workers to protect the user and patient against transfer of microorganisms, blood and body fluids, and airborne particulates. The WestTec Procedure and Surgical facemasks are single use, disposable devices provided non-sterile.
The WestTec Procedure and Surgical facemasks are identical with the exception that the Surgical Mask has a Comfort Band to keep the inner layer away from the user's mouth to provide space between the users face and the mask making it more comfortable to wear. Both facemasks are manufactured with three layers of nonwoven polypropylene materials. The facemasks are held in place over the user's mouth and nose by two elastic ear loops welded to each facemask. The elastic ear loops are not made with natural rubber latex. The facemasks have a malleable Nose Band contained in the layers of the facemask to allow the user to fit the facemask around their nose. The facemasks are sold non-sterile and are intended to be a single use, disposable device.
The document describes the acceptance criteria and study results for WestTec Procedure and Surgical facemasks, which are intended to be substantially equivalent to the predicate device, Jingzhou Haixin Green Cross Medical Products Co., Ltd Surgical Mask (K123787). The devices are classified as Class II surgical apparel under 21 CFR 878.4040.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the WestTec facemasks are based on the ASTM F2100 Standard Specification for Performance of Materials Used in Medical Face Masks for Level 2 performance classification.
| Description | ASTM F2100 Requirement for Level 2 Classification | WestTec Masks Performance | Predicate Device (K123787) Performance |
|---|---|---|---|
| Fluid Resistance Performance ASTM F1862 | 29 out of 32 pass at 120mmHg | 32 out of 32 pass at 120mmHg | 29 out of 32 pass at 120mmHg |
| Particulate Filtration Efficiency ASTM F2299 | ≥98% | 98.0% | 99.1% |
| Bacterial Filtration Efficiency ASTM F2101 | ≥98% | 99.7% | 99.8% |
| Differential Pressure (Delta P) MIL-M-36954C |
§ 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.