(107 days)
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):
| Items | Performance Report | Acceptance Criteria (Level 2, ASTM F2100-19) | Result |
|---|---|---|---|
| Bacterial filtration efficiency (BFE) (%) | 99.9% | ≥98% | Pass |
| Differential pressure (mmH2O/cm²) | 2.8-3.6 mmH2O/cm² |
§ 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.