(42 days)
The TAIJI Professional Series Level 3 Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single use, disposable device, provided non-sterile.
The TAIJI Professional Series Level 3 Surgical Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided nonsterile.
This document pertains to the 510(k) premarket notification for a medical device: TAIJI Professional Series Level 3 Surgical Face Mask (K211861).
The acceptance criteria and study proving the device meets these criteria are outlined in the "Summary of Non-Clinical Testing" section.
Here's the breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Standard/Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood | Barrier Testing | At least 29 out of 32 specimens show passing results at 160 mmHg | Samples met the predetermined acceptance criteria. |
| ASTM F2101-19: Standard Specification for Performance of Materials Used in Medical Face Masks | Barrier Testing | ≥98% | Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each). |
| EN 14683:2019 Annex C and ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks | Physical Testing |
§ 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.