(24 days)
The Stryker T4 Hood, Zippered Toga, and Pull-over Toga are components of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
The Stryker T4 Personal Protection System: Stryker T4 Hood, Zippered Toga, and Pull-over Toga
This document is a 510(k) clearance letter from the FDA for a medical device called the "Stryker T4 Hood, Stryker T4 Zippered Toga, Trade Name: Stryker T4 Pull". It acknowledges that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria for the device's performance, nor does it describe any study conducted to prove the device meets such criteria.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness. It does not typically involve detailed performance studies with acceptance criteria in the same way a Premarket Approval (PMA) application would for high-risk devices.
Therefore, I cannot provide the requested information based on the provided text. The document is solely an FDA clearance letter.
§ 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.