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510(k) Data Aggregation
(107 days)
The Disposable 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.
In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile. The surgical gown has six sizes - S, M, L, XL, XXL and XXXL.
The Disposable surgical gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
The document details the non-clinical testing performed for the Disposable Surgical Gown (G4003) to support its substantial equivalence claim.
1. Table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Tearing Strength | Evaluate the tearing strength of the test sample. | ≥ 10N | Pass: MD: average 52.03N, CD: average 29.15N |
| Tensile Strength | Evaluate the breaking strength of the test sample. | ≥ 30N | Pass: MD: average 135.83N, CD: average 98.25N |
| Seam Strength | Evaluate the seam strength of the test sample. | ≥ 30N | Pass: Average 45.18N |
| Impact Penetration | Evaluate the water impact of the test sample. | ≤1.0 g | Pass: 0.16g max |
| Hydrostatic Pressure | Determine the hydrostatic pressure of the test sample. | >50 cm | Pass: 52~98cm |
| Thermal and Evaporative Resistance | Evaluate the evaporative resistance of the test sample. | < 3 Pa.m²/W. | Pass: 0.00542 Pa.m²/W |
| Linting | Evaluate the linting of the test sample. | Log10 <4 | Pass: Average 2.2 |
| Flammability | Evaluate the flammability of the test sample. | Class 1 | Pass: Class 1 |
| EO/ECH residue | Evaluate the level of sterilant residues. | EO: < 10 ug/cm²ECH: < 10 mg/device | EO: not detectedECH: Average 6.8 ug/device |
| In Vitro Cytotoxicity (ISO 10993-5) | Demonstrate the safety of the subject device. | Non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Irritation and Skin Sensitization (ISO 10993-10) | Demonstrate the safety of the subject device (purpose not explicitly stated for irritation/sensitization but implied for biocompatibility). | Non-irritatingNon-sensitizing | Under the conditions of the study, the device is non-irritating and non-sensitizing. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific non-clinical test. However, the tests are performed according to recognized international and national standards (e.g., ASTM, AATCC, ISO, CPSC). Data provenance is from Xiantao Topmed Nonwoven Protective Products Co., Ltd. located in Hubei Province, China, likely from prospective testing specifically conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the document describes non-clinical performance and biocompatibility testing of a physical product (surgical gown), not a diagnostic or AI device that requires expert ground truth establishment. The "ground truth" for these tests is defined by the objective measurement criteria within the specified standards.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving multiple readers, not for objective non-clinical performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The device is a physical surgical gown, not an AI or diagnostic tool, so no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a physical surgical gown, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For these non-clinical tests, the "ground truth" is established by objective measurements and results obtained from standardized testing methodologies, as defined by the various ASTM, AATCC, ISO, and CPSC standards cited (e.g., tearing strength in Newtons, impact penetration in grams, hydrostatic pressure in cm).
8. The sample size for the training set
This section is not applicable. The device is a physical surgical gown. There is no concept of a "training set" as there would be for an AI or machine learning model.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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(88 days)
The Disposable Medical 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 is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of Galvanized iron wire coated by PE, and the ear loop is made of polyester and spandex.
The disposable medical face masks are sold non-sterile and are intended to be single use, disposable devices.
This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask. It focuses on demonstrating that the proposed device is substantially equivalent to a legally marketed predicate device (K210433) by providing non-clinical test data.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|
| Fluid Resistance: 29 out of 32 pass at 160 mmHg | Pass: 32 out of 32 pass at 160 mmHg, 3 lots |
| Particulate Filtration Efficiency: $\ge$ 98% | Pass: Average 99.36% |
| Bacterial Filtration Efficiency: $\ge$ 98% | Pass: Average 99.40% |
| Differential Pressure (Delta P): < 6.0mmH2O/cm² | Pass: Average 2.8mmH2O/cm² |
| Flammability: Class 1 | Pass: Class 1 |
| Cytotoxicity: Non-cytotoxic | Pass: Under the conditions of the study, the device is non-cytotoxic. |
| Irritation: Non-irritating | Pass: Under the conditions of the study, the device is non-irritating. |
| Sensitization: Non-sensitizing | Pass: Under the conditions of the study, the device is non-sensitizing. |
2. Sample size used for the test set and the data provenance:
- Fluid Resistance: 32 samples per lot, across 3 lots.
- Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Cytotoxicity, Irritation, Sensitization: The document does not specify the exact sample size for these tests, only that the results passed. The provenance of the data is not explicitly stated beyond originating from "Non-Clinical Test Conclusion," which implies laboratory testing. The manufacturer is Xiantao Topmed Nonwoven Protective Products Co., Ltd. in China, so the testing was likely conducted in China. The data is retrospective in the sense that it was collected as part of the submission process to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This submission does not involve expert-established ground truth in the context of diagnostic interpretation. It relies on standardized laboratory testing and established regulatory guidance (ASTM F2100, F1862, F2101, F2299, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10) for evaluating the performance of the face mask. The "ground truth" for each performance metric is defined by the acceptance criteria of these standards. The experts would be the accredited laboratory personnel performing these standardized tests,
but their specific number and qualifications are not detailed in this document.
4. Adjudication method for the test set:
Not applicable. The tests are objective, standardized laboratory tests with defined passing criteria. There is no subjective interpretation or adjudication needed for the results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a medical face mask, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical face mask, not an AI-powered algorithm. It does not have a "standalone" or "human-in-the-loop" performance in the context of an algorithm.
7. The type of ground truth used:
The ground truth is based on pre-defined, internationally recognized technical standards and test methodologies for medical face mask performance, such as ASTM F2100, F1862, F2101, F2299, EN 14683, 16 CFR 1610, and ISO 10993 for biocompatibility.
8. The sample size for the training set:
Not applicable. This is a physical medical device (face mask), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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