(412 days)
INTAI Surgical Mask is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. This is a single use, disposable device and provided non-sterile.
The INTAI Surgical Mask is single use, three-layers, flat-pleated masks with ear loops, and nose clip. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The ear loops welded are used to keep the mask close to the mouth and the nose. The ear loops are made of Nylon. The nose clip, which is made by plasticity material (HDPE), contained in masks is in the layers of the surgical mask to allow the users to fit the facemask around their nose. The surgical mask are provided in one color (blue), non-sterile and intended to be single use, disposable device.
This document is a 510(k) premarket notification for a medical device, specifically the INTAI Surgical Mask. It details the device's characteristics and its comparison to a legally marketed predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document presents the acceptance criteria and performance results directly in Table 2: Comparison of Performance testing on page 5 and the subsequent Summary of Non-Clinical Test table on page 6.
| Item | Reported Device Performance (K210422) | Acceptance Criteria (Level 3) | Result |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood | Achieve a 4% AQL at 160mmHg | Achieve a 4% AQL (29 out of 32 pass at 160mmHg) | Pass |
| Sub-Micron Particle Filtration Efficiency (PFE) | ≥98% | ≥98% | Pass |
| Differential Pressure |
§ 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.