(127 days)
proMedical Products Co. LTD intends to market Non-sterile surgical gowns identified in 21 CFR 878.4040 as medical devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from the transfer of microorganisms, bodily fluids and particulate material.
Surgical Gowns
This document is an FDA 510(k) clearance letter for "Surgical Gowns" (K042111) and does not contain information about the acceptance criteria or a study proving that a device meets those criteria, as typically found in a clinical study report or a summary of safety and effectiveness (SSE).
Instead, this letter:
- Confirms substantial equivalence: It states that the device is substantially equivalent to legally marketed predicate devices.
- Specifies regulation information: It lists the regulation number, name, and product code.
- Outlines general regulatory requirements: It reminds the applicant about various FDA regulations they must comply with, such as annual registration, labeling, and good manufacturing practices.
- Includes "Indications for Use": This section describes the intended purpose of the surgical gowns (protection from microorganisms, bodily fluids, and particulate material) but does not provide specific performance metrics or acceptance criteria from a study.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone), or training set information from the provided text. This type of information would typically be detailed in the 510(k) submission itself or a separate study report, not in the FDA's 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.