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Disposable surgical mask (non sterile) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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.

The Disposable surgical mask (non sterile) is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The Disposable surgical mask (non sterile) will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

The provided text describes a 510(k) premarket notification for a Disposable Surgical Mask (non-sterile), K211451, submitted by Qinhuangdao Taizhi Medical Technology Co., Ltd. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K182515, Surgical Face Mask by Wuhan Dymex Healthcare Co., Ltd.) through non-clinical testing.

Based on the provided text, the device in question is a Disposable Surgical Mask, not an AI or imaging device. Therefore, many of the requested criteria (e.g., sample size for test set/training set, expert qualification, adjudication method, MRMC study, standalone performance, type of ground truth) typically associated with the development and validation of AI/ML-based medical devices or diagnostic tools are not applicable.

The acceptance criteria and study proving the device meets them are related to the physical and performance characteristics of a surgical mask, as per established standards and guidance for such products.

Here's the information extracted from the document, tailored to the nature of this device:

Acceptance Criteria and Device Performance for Disposable Surgical Mask (K211451)

The device demonstrates conformance to recognized standards and requirements for surgical face masks through non-clinical performance and biocompatibility testing. The testing was conducted to establish substantial equivalence to a predicate device (K182515).

1. Table of Acceptance Criteria and Reported Device Performance

The following table summarizes the performance testing results against established acceptance criteria for surgical masks (specifically, Level 2, ASTM F2100-19):

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