(98 days)
Surgical Gown is intended to be worn by room personnel during surgical procedures or other invasive tests to protect both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This is single use, disposable device, provided sterile.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 2 classification, and the reinforced surgical gowns met the requirements for Level 3 classification.
The proposed devices Surgical Gown / Reinforced Surgical Gown have two models: ZSG1005 and ZSG1006.
The proposed device Surgical Gown is model ZSG1005, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in M, L, XL sizes. This proposed device can meet the requirements for Level 2 per ANSI/AAMI PB70:2012.
The proposed device Reinforced Surgical Gown is model ZSG1006, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in M. L. XL sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed devices are disposable medical devices and provided in sterile.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Surgical Gown, Reinforced Surgical Gown (Wuhan Zonsen Medical Products Co.,Ltd)
1. Table of acceptance criteria and the reported device performance:
| Item | Acceptance Criteria | Reported Device Performance (Surgical Gown / Reinforced Surgical Gown) |
|---|---|---|
| Flammability | Meets Class 1 requirements | Class 1 / Class 1 (PASS) |
| Hydrostatic pressure | Surgical Gown (Level 2): >20 cm | |
| Reinforced Surgical Gown (Level 3): >50 cm | 60 cm / 95 cm (PASS) | |
| Water impact | ≤1.0 g | 0.1 g / 0 g (PASS) |
| Breaking strength | >20N | 124N / 123N (PASS) |
| Tearing strength | >20N | 52N / 61N (PASS) |
| Linting | $Log_{10}(particle\ count) 20 cm, flammability Class 1). |
8. The sample size for the training set:
- Not applicable. This device is a physical product, not a machine learning model, therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth established for it.
§ 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.