Search Results
Found 2 results
510(k) Data Aggregation
(89 days)
Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
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) |
Ask a specific question about this device
(168 days)
Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
The Sterile Triplex Surgical Gown (S, M, L, XL, XXL, is a sterile single-use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
They have been tested and are classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding a Sterile Triplex Surgical Gown. It clears the device for marketing due to its substantial equivalence to legally marketed predicate devices.
The information provided in the document is about the regulatory clearance for a physical medical device (surgical gown) based on its performance in barrier tests, not an AI/ML medical device. Therefore, the questions about acceptance criteria for an AI/ML model, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable to this document.
The document states:
- Trade/Device Name: Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
- Regulation Number: 21 CFR 878.4040
- Regulation Name: Surgical Apparel
- Regulatory Class: Class II
- Product Code: FYA
- Indications for Use: To protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
- Performance Claim: "They have been tested and are classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities."
Since the request is specifically about a study proving device performance using AI/ML-related metrics, and this document pertains to a physical sterile gown, I cannot extract the requested information.
Ask a specific question about this device
Page 1 of 1