(268 days)
The Disposable Surgical Isolation Gown is intended to protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the disposable surgical isolation gown meets the requirements of a Level 4 barrier protection per ANSI/AAMI PB70:2012 -Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
The disposable surgical isolation gown consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings,The products are composed of 45g of SMS (spunbond, meltblown, spunbond) non-woven fabric and 20g of PE(Polyethylene) film layer material with the color in blue.Disposable surgical isolation gown have a hook and loop fastener at the back of the neck and a waist ties feature to secure the gown to the body of the user. The material of the collar of the Disposable Surgical Isolation Gown is 35g of white PP (polypropylene). The cuffs are white polyester rib sleeve cloth with a length of 7.5cm. The disposable surgical isolation gown provided in ONE product model in six sizes. The size of disposable surgical isolation gown is divided into six groups: S, M, L, XL, XXXL. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the disposable surgical isolation gown meet the requirements for Level 4 classification.
The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
The provided text describes the acceptance criteria and study for a Disposable Surgical Isolation Gown, not an AI device. As such, information regarding AI-specific details like effect size improvement with AI assistance, standalone algorithm performance, or ground truth establishment for AI training sets is not present. Therefore, the response will focus on the details pertinent to the medical device described.
Acceptance Criteria and Device Performance for Disposable Surgical Isolation Gown
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Weight per square (g) (ASTM D3776) | ≥65g/m² | Lot A: 66.88 g/m² | |
| Lot B: 67.86 g/m² | |||
| Lot C: 66.92g/m² | Pass | ||
| Flammability (16 CFR Part 1610) | Class 1: Burn time ≥ 3.5 seconds | Class 1 (Results obtained from Three Lots) | Pass |
| Liquid Barrier Performance (AATCC-127) - Hydrostatic Pressure | > 50 cm H₂O | > 50 cm H₂O (3 non-consecutive lots tested, using a sample size of 32/lot) | Pass |
| Liquid Barrier Performance (AATCC-42) - Water Impact | ≤ 1.0 g | ≤ 1.0 g (3 non-consecutive lots tested, using a sample size of 32/lot) | Pass |
| Liquid Barrier Performance (ASTM F1671/F1671M-2013) - Blood-Borne Pathogen | 1. Assay titer (PFU/mL) |
§ 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.