(89 days)
The Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a 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 and Reinforced Surgical Gown met the requirements for Level 3 classification.
The proposed device Surgical Gown its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes . This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed device Reinforced Surgical Gown is its body, sleeve and belt are made of SMMS nonwoven 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 S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) 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.
The provided FDA 510(k) summary for the Surgical Gown and Reinforced Surgical Gown details the device's technical specifications and non-clinical testing for substantial equivalence to a predicate device, rather than an AI/ML-driven medical device. Therefore, the information requested regarding acceptance criteria, study methodologies, and performance related to AI/ML device evaluation (such as sample sizes for test/training sets, expert consensus, MRMC studies, or ground truth establishment) is not applicable to this document.
The document focuses on the physical and barrier properties of surgical gowns. Here is a summary of the acceptance criteria and performance as presented in the non-clinical testing section:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Seam strength | ASTM D1683M-17 | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (59.21 N average from 30 samples) |
| Breaking strength | ASTM D5034-09 (2017) | ≥ 30N (7lbf) per standard F2407-20 for level 3 | PASS (MD: 144.87N, CD: 88.89N average from 30 samples) |
| Tear strength (N) | ASTM D5587-15 | ≥ 10N | PASS (MD: 69.61N, CD: 32.25N average from 30 samples) |
| Lint and other generation in dry state | ISO 9073-10:2003(E) | Log10(particle count) |
§ 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.