(90 days)
The Hygenix is intended to be worn to protect both the patient and health care 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 fluids. This device is disposable, non-sterile and for single use only.
The Hygenix is a 3 Ply flat- pleated and Disposable surgical mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PC coated Aluminium wire. The model ear loop is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of Polyester and Spandex. The dimensions of the Mask are: length- 175 ± 5 mm and width- 95 ± 5 mm. These masks are single-use, disposable devices, provided non-sterile.
Here's an analysis of the Hygenix device based on the provided FDA 510(k) summary, specifically focusing on its acceptance criteria and the study that proves it meets those criteria.
Acceptance Criteria and Device Performance for Hygenix (K232797)
The Hygenix device is a 3-ply disposable mask, and its performance is evaluated against established standards for surgical masks. The study proving its compliance is a non-clinical performance and biocompatibility testing regime.
1. Table of Acceptance Criteria and Reported Device Performance
| SI No. | Purpose | Reference Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| 1. | Fluid resistance | ASTM F1862/F1862M-17 | Pass at 160 mmHg | Pass at 160 mmHg |
| 2. | Particulate Filtration Efficiency (PFE) | ASTM F2299/F2299M-03(2017) | ≥ 98% | > 98% (Pass) |
| 3. | Bacterial Filtration Efficiency (BFE) | ASTM F2101-19 | ≥ 98% | > 98% (Pass) |
| 4. | Differential pressure (ΔP) | EN 14683 (Annex C): 2019 |
§ 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.