(85 days)
Exact Medical Manufacturing Surgical Gown - Spunlace w/PE Layer are sterile single use 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.
The Exact Medical Manufacturing Surgical Gown - Sounlace w/PE Laver are also sold as built nonsterile, single use items, to repackagerrelabeler establishments for further packaging and ethylene oxide sterilization.
Exact Medical Manufacturing Surgical Gown-SPL are single use, disposable surgical gowns using in the OR as a protective covering, for the operating room staff, from the transfer of microorganisms, body fluids and particulates. Exact Medical Manufacturing Surgical Gowns- Spunlace w/PE Layer are comprised of disposable nonwoven (Spunlace), 100% polyester cuffs, Velcro neck closure, reinforced areas fabric or polyethylene
This document describes the 510(k) submission for Exact Medical Manufacturing's Surgical Gowns – Spunlace w/PE Layer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI-based device. Therefore, many of the requested categories related to AI device evaluation (e.g., AI integration, multi-reader multi-case studies, training set details) are not applicable.
Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from "met acceptance criteria") | Reported Device Performance |
|---|---|---|
| Barrier Properties | Equivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards. | "All results of the testing met acceptance criteria." |
| Tensile Strength | Equivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards. | "All results of the testing met acceptance criteria." |
| Tear Strength | Equivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards. | "All results of the testing met acceptance criteria." |
| Flammability | Equivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards. (Typically per 16 CFR Part 1610 for apparel textiles.) | "All results of the testing met acceptance criteria." |
| Linting | Equivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards. | "All results of the testing met acceptance criteria." |
| Sterility | Achieves sterility through Ethylene Oxide (ETO) process meeting AAMI 11135-1:2007 (Sterilization of Healthcare Products) with specific parameters: |
- Pre-Conditioning: Temperature = 42°C, RH = 60%, Dwell Time = 6 hours
- EO Cycle: Temperature = 54°C, RH >= 30%, EO Concentration = 730mg/m3, Dwell Time = 9 hours
- Aeration: Temperature = ambient, Time >= 72 hours
- EO Residuals: EO
§ 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.