(126 days)
Medline Prevention ™ Disposable Surgical Gowns are surgical apparel 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 body fluids, micro-organisms, and particulate material.
Medline Prevention Surgical Gowns
This document is a 510(k) premarket notification letter from the FDA to Medline Industries, Incorporated, regarding their "Medline Prevention Surgical Gowns." This type of document is a regulatory approval, not a description of a study proving device performance against acceptance criteria.
The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device is considered as safe and effective as a device already on the market, but it does not include information about a specific study with acceptance criteria and a detailed analysis of device performance.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria based solely on the provided text. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts to establish ground truth.
- Adjudication methods.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This document is solely focused on the regulatory approval process through the 510(k) pathway, which relies on demonstrating substantial equivalence, often through comparisons to an existing predicate device's performance, rather than providing raw study data or acceptance criteria for a new, independent performance study.
§ 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.