(155 days)
The device 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 is a single use, disposable device, provided non-sterile.
The proposed devices, Standard Procedure Mask and Standard Surgical Mask, are a three-layer, singleuse, flat-pleated mask. Both the two masks have the same indications for use. The Standard Procedure Mask is an ear-loop surgical mask, and the Standard Surgical Mask is a tie-on surgical mask. The color of the proposed devices is blue. They are provided in non-sterile.
This document describes the performance testing of a medical device, specifically a Standard Procedure Mask and a Standard Surgical Mask, to demonstrate substantial equivalence to a predicate device (K153496) for FDA 510(k) clearance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood | To evaluate the effectiveness of the test sample from possible exposure to blood and other body fluids. | No penetration at 120 mmHg | Pass at 120mmHg |
| Bacterial Filtration Efficiency (BFE) | To determine the bacterial filtration efficiency (BFE) of the test article. | $\ge 98%$ | Average 98.61% |
| Particulate Filtration Efficiency (PFE) | To determine the Particle Filtration Efficiency. | $\ge 98%$ | Average 98.58% |
| Differential Pressure (Breathability) | To determine the differential pressure, indicating how easily one can breathe through 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.