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510(k) Data Aggregation
(89 days)
Xiantao Zhibo Non-Woven Products Co., Ltd.
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) |
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(134 days)
Xiantao Zhibo Non-woven Products Co., Ltd
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The proposed device(s) are White color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) premarket notification for a Surgical Face Mask. It details the device's technical characteristics, intended use, and comparison to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the standards for a Level 2 surgical face mask, primarily following ASTM F2100-11.
| Acceptance Criteria (ASTM F2100-11 Level 2 Standard) | Proposed Device Performance | Predicate Device Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862 at 120 mmHg) | 32 out of 32 pass | 32 out of 32 pass |
| Particulate Filtration Efficiency (ASTM F2299) | 99.88% pass | 98.46% pass |
| Bacterial Filtration Efficiency (ASTM F2101) | 99.6% pass | 98.7% pass |
| Differential Pressure (Delta P) (MIL-M-36954C) | 3.0 mmH2O/cm² pass | 4.2 mmH2O/cm² pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1 |
| Biocompatibility - Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility - Irritation | Non-irritating | Non-irritating |
| Biocompatibility - Sensitization | Non-sensitizing | Non-sensitizing |
2. Sample Size and Data Provenance for Test Set
- Fluid Resistance (ASTM F1862): 32 samples were tested. The country of origin for the data is not explicitly stated but implied to be from the manufacturer's testing (Xiantao Zhibo Non-woven Products Co., Ltd in China). The data is from non-clinical performance testing.
- For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), specific sample sizes are not provided in the summary, but the results indicate tests were conducted and met the criteria. The data provenance is non-clinical performance testing, likely conducted by or for the manufacturer.
3. Number of Experts and Qualifications for Ground Truth
This document describes technical performance testing of a physical device (surgical face mask), not an AI/software device that requires expert review for ground truth. Therefore, this section is not applicable. The "ground truth" here is established by standardized laboratory testing methods and measured physical properties.
4. Adjudication Method for Test Set
Not applicable, as this is laboratory testing of a physical product against defined standards, not an expert-driven assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a premarket notification for a physical medical device (surgical face mask), not an AI/software device that would typically undergo MRMC studies to assess human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable, as this is a physical medical device.
7. Type of Ground Truth Used
The ground truth is established through standardized laboratory testing protocols and measurements according to recognized consensus standards such as ASTM F2100-11, ASTM F1862, ASTM F2101, MIL-M-36954C, 16 CFR 1610, and ISO 10993 for biocompatibility. These standards define the methods and acceptance criteria for measuring specific physical and biological properties of the face mask.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device.
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