(219 days)
The Medline Orbis Surgical Gown is a single use, Level 4 surgical gown intended to be worn by healthcare professionals during surgical procedures to help protect both the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.
The Medline Orbis Surgical Gown meets the Level 4 requirements in accordance with ANSI/AAMIPB70:2012 "Liquid barrier and performance classification of protective apparel and drapes intended for use in healthcare facilities".
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I am sorry, but based on the provided document, I cannot answer the question as it pertains to the acceptance criteria and study proving a device meets these criteria. The document is an FDA clearance letter for a "Medline Orbis Surgical Gown" and primarily discusses regulatory classifications, general controls, and compliance requirements. It does not contain information about:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance (country, retrospective/prospective).
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm-only) performance.
- Type of ground truth used (e.g., pathology, outcomes).
- Sample size for the training set or how its ground truth was established.
The document only states that the surgical gown "meets the Level 4 requirements in accordance with ANSI/AAMIPB70:2012 'Liquid barrier and performance classification of protective apparel and drapes intended for use in healthcare facilities'." This indicates a standard was met, but it does not detail the specific acceptance criteria within that standard or the study results that demonstrate compliance.
§ 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.