(35 days)
The 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 masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
Level 2 Face Mask Models: FCY-L2-E, FCY-L2-T
Level 3 Face Mask Models: FCY-L3-E, FCY-L3-T
The Proposed device has one size 17.5 cm x 9.5 cm and two wear types of Ear Loops and Tie-On. They are available in blue and white colors and three barrier levels (Level 3) according to ASTM F2100:2019. The proposed Level 2 and Level 3 masks are the same product which can pass ASTM F2100-19 Level 2 & 3 at the same time; they are classified into level 3 just because of the marketing strategies. All the materials of proposed tie-on masks are included in ear loops masks. The outer layer, inner layer, middle melt-blown layer and PET coated iron wire nose clip of tie-on masks are exactly the same with ear-loop masks, the tie tapes of tie-on masks are same as the outer layer of white mask body but 3 layers folded and physically ultrasonic welding together. The proposed mask can form a physical barrier by being worn on the mouth and nose of medical staff to protect both the patient and healthcare personnel from the spread of microorganisms, blood and body fluids, and particulate materials. The proposed subject device, surgical face mask, operates by acting as a physical barrier. The barrier protects the medical staff, patient, and healthcare personnel from the spread of microorganisms, blood and body fluids, and particulate materials. The barrier goes over the mouth and nose of the user.
This document is a 510(k) Pre-Market Notification for a Surgical Face Mask. It details the performance criteria and the testing conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information, structured to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for surgical face masks are standardized by ASTM F2100-19. The table below outlines these criteria and the reported performance of the proposed device (K210225) for Level 2 and Level 3 masks. The predicate device (K160269) is also included for comparison.
| Performance Characteristic | ASTM F2100-19 Level 2 Acceptance Criteria | Proposed Device (K210225) Performance (Level 2) | ASTM F2100-19 Level 3 Acceptance Criteria | Proposed Device (K210225) Performance (Level 3) | Predicate Device (K160269) Performance (Level 2) | Predicate Device (K160269) Performance (Level 3) |
|---|---|---|---|---|---|---|
| Fluid Resistance | 120 mmHg | Pass at 120 mmHg | 160 mmHg | Pass at 160 mmHg | Pass at 120 mmHg | Pass at 160 mmHg |
| Particulate Filtration Efficiency (PFE) | ≥ 98% | Pass at 99.5% | ≥ 98% | Pass at 99.5% | Pass at 99.6% | Pass at 99.7% |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | Pass at 99.9% | ≥ 98% | Pass at 99.9% | Pass at >98% | Pass at >99% |
| 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.