Search Results

The Single-Use Surgical Mask with Ear Loop is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile. Model: M and L, blue color, and Level 2 barrier level as ASTM F2100.

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven fabric, and the middle layer is made of Melt-blown non-woven fabric. The blue colorant is bule masterbatch. The Single-Use Surgical Mask with Ear Loop is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with Polyester. The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices. There are two models included, Model M and L. The two models share the same indication for use, instruction for use, material used, and structure. The only difference is the dimension.

The provided text describes the acceptance criteria and study results for the "Single-Use Surgical Mask with Ear Loop" (K201691), demonstrating its substantial equivalence to a predicate device (K153496).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device