# K201896: ivi N3003 Surgical face Mask, ivi N6006 Surgical mask

- Pathway: 510(k) (Traditional)
- Applicant: Iob Medical, Inc.
- Decided: Mar 30, 2021 after 265 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K201896
Methodology: https://510kreport.com/methodology