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The ivi N3003 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.

The ivi N6006 Surgical Mask is single-use, disposable device, provided non-sterile, and intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "ivi N3003 Surgical Face Mask" and "ivi N6006 Surgical Mask" does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.

The document is a standard FDA clearance letter for a Class II medical device (surgical masks), focusing on:

• Substantial equivalence determination.
• Regulatory requirements (registration, listing, GMP, labeling, etc.).
• Indications for Use for both mask models.
• Paperwork Reduction Act information.

It does not describe the technical performance of the masks (e.g., filtration efficiency, breathability) or any studies related to proving such performance beyond stating their intended use for protection against microorganisms, body fluids, and particulate material. There is no mention of AI, machine learning, or software-driven device performance.

Therefore, I cannot provide the requested information, which typically applies to AI/ML device submissions, based on the content of this document.

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