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510(k) Data Aggregation
(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) < 4 | PASS (1.9 average from 6 samples) |
| Flammability | CPSC 16 CFR Part 1610-2008 | Class I | PASS (Class I) |
| Water Penetration Resistance | AATCC 42-2013 | ≤ 1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | PASS (≤ 1.0g) |
| Static hydrostatic resistance | AATCC 127-2014 | ≥ 50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 AQL: 4% | PASS (≥ 50 cm) |
| EO and ECH sterilization residual | ISO 10993-7:2008 | EO ≤ 4mg/d, ECH ≤ 9mg/d | PASS (EO ≤ 4mg/d, ECH ≤ 9mg/d) |
| Cytotoxicity | ISO 10993-5 | Non-Cytotoxic | PASS (Non-cytotoxic) |
| Irritation | ISO 10993-10 | Non-Irritating | PASS (Non-irritating) |
| Sensitization | ISO 10993-10 | Non-Sensitizing | PASS (Non-sensitizing) |
2. Sample sizes for test set and data provenance:
- Seam strength: Reported result is an average from 30 samples.
- Breaking strength: Reported result is an average from 30 samples.
- Tear strength: Reported result is an average from 30 samples.
- Lint and other generation in the dry state: Reported result is an average from 6 samples.
- The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, beyond stating "Non-clinical tests were conducted to verify that the proposed device met all design specifications."
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- This is not applicable as the device is a physical product (surgical gown) and not an AI/ML-driven device requiring expert interpretation for ground truth. Performance is measured against established physical and chemical standards.
4. Adjudication method for the test set:
- Not applicable for physical product testing. Performance is determined by quantitative measurements against predefined criteria in laboratory settings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Not applicable. This type of study is relevant for AI-assisted diagnostic or interpretative devices, not for surgical gowns.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML driven device.
7. The type of ground truth used:
- The "ground truth" for this device's performance is established by physical and chemical measurement standards (e.g., ASTM, ISO, AATCC, CPSC standards) and the specified acceptance criteria for each test. For example, a seam strength greater than or equal to 30N is the "ground truth" for acceptable seam strength.
8. The sample size for the training set:
- Not applicable. There is no AI/ML component requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML component or training set.
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