(74 days)
The Gerson Model 2130 /2131 Disposable Surgical N95 Particulate Respirators are intended to be worn by operating room personnel during surgical procedures to protect the wearer from transfer of both the surgical patient and particulate material. The respirator is a single-use disposable.
The 2130 and 2131 Model respirators are available in either blue or white colors.
This device also meets CDC Guidelines for TB Exposure Control.
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This document is a 510(k) clearance letter from the FDA for the Gerson Model 2130/2131 Surgical N95 Particulate Respirators. It does not contain information about acceptance criteria or a study proving device performance in the context of the requested information. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance study results against specific criteria.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample size, ground truth details, MRMC study, standalone performance, training set details) from the provided text.
§ 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.