(434 days)
Surgical gowns are intended to be worn by operating room personnel procedure to protect both the surgical patient and the operating room persomel from transfer of microorganisms, body fluids, and particulate material. This device is provided sterile.
Per ASNI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 classification.
Surgical gowns are intended to be worn by healthcare professionals to protect both the patient and the healthcare professional from the transfer or microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and ethylene oxide (EO) sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL.
The proposed surgical gowns are constructed of a Spunbond (SMS) nonwoven material, with cuffs made of polyester and elastic, offered in standard (non-reinforced) and reinforced surgical gowns, in blue color.
This is a 510(k) summary for a surgical gown, which is a low-risk medical device. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of AI algorithm performance. Therefore, many of the requested criteria, which are typically relevant for AI/ML device evaluations, are not applicable here.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document provides a summary of performance testing in Table 2, outlining the test method, purpose, acceptance criteria, and result (Pass/Fail or specific finding).
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| AATCC 127 | Hydrostatic pressure | Level 2 > 20 cm, Level 3 > 50 cm | Pass |
| AATCC 42 | Impact penetration | ≤1g | Pass |
| ASTM F 2407 (ASTM D 5034) | Tensile Strength | Length Direction ≥ 115N, Width Direction ≥ 115N | Pass |
| ASTM D 5587 | Tearing strength by Trapezoid | Length Direction > 20 N, Width Direction > 20 N | Pass |
| ASTM D 1683 | Seam strength | ≥ 20 N | Pass |
| 16 CFR Part 1610 | Flammability of Textiles | Class 1 | Class 1 |
| ISO 10993-7 | Ethylene oxide residues | EO residual ≤ 4 mg/device, ECH residual ≤ 9 mg/device | Pass |
| ISO 9073-10 | Linting | Log10 |
§ 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.