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510(k) Data Aggregation
(99 days)
The Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device, Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and include variations of different sizes from X-Small to X-large. The color of the proposed device is Blue and Indigo
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
The provided document is a 510(k) Pre-Market Notification for a Powder Free Nitrile Examination Glove. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than a study proving the device meets acceptance criteria for an AI/CADe system. Therefore, I cannot provide details related to AI/CADe specific criteria such as ground truth, expert adjudication, or MRMC studies.
However, I can extract the acceptance criteria and reported device performance for the glove itself, based on the non-clinical tests described in Section 8.0, "Summary of Non-Clinical Testing."
Here is the requested information for the medical glove, structured as closely as possible to your prompt, while acknowledging the limitations of the provided document for AI/CADe specific questions:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria (Proposed Device) | Reported Device Performance (Proposed Device - Blue/Indigo) |
|---|---|---|---|
| ASTM D5151 | Testing for Freedom from holes | Freedom from holes (AQL: 1.5) | No water leakage inspected from 200 samples. |
| ASTM D6124 | Determine the powder residue for powder free gloves | < 2.0 mg per glove | Residual Powder: Average 0.38 mg. |
| ASTM D6319 (Physical Properties) | Testing for Physical property characteristics | Before Aging: Tensile Strength: 15 MPa, min Ultimate Elongation: 500 % min After Aging: Tensile Strength: 14 MPa, min Ultimate Elongation: 500 % min | Before Aging: Tensile Strength: ≥ 17 MPa Ultimate Elongation: ≥ 512% After Aging: Tensile Strength: ≥ 17 MPa Ultimate Elongation: ≥ 508% |
| ASTM D6319 (Dimensions) | Testing For physical dimensions specification | Length: 230 mm ±10 for all size (XS, S, M, L, XL)Width: 70±10 mm for XS; 80±10 mm for S; 95±10 mm for M; 110±10 mm for L; 120±10 mm for XL.Finger Thickness: 0.12±0.03 mmPalm Thickness: 0.10±0.03 mmAll acceptance criteria above meet the requirements in Table 2 Dimensions and Tolerances of ASTM D6319 | Length of Size XS: ≥ 229 mm; Width of Size XS: ≥70 (70-73) mm; Palm Thickness of Size XS: ≥0.09 mm; Finger Thickness of Size XS: ≥0.11 mm.Length of Size S: ≥ 230 mm; Width of Size S: ≥85 (85-86) mm; Palm Thickness of Size S: ≥0.09 mm; Finger Thickness of Size S: ≥0.11 mm.Length of Size M: ≥ 230 mm; Width of Size M: ≥95 (95-96) mm; Palm Thickness of Size M: ≥0.09 mm; Finger Thickness of Size M: ≥0.11 mm.Length of Size L: ≥ 230 mm; Width of Size L: ≥108 (108-110) mm; Palm Thickness of Size L: ≥0.09 mm; Finger Thickness of Size L: ≥0.11 mm.Length of Size XL: ≥ 230mm; Width of Size XL: ≥120 (120-121) mm; Palm Thickness of Size XL: ≥0.09 mm; Finger Thickness of Size XL: ≥0.11 mm. |
| ISO 10993-11 | Evaluate the endpoint of systemic toxicity for biocompatibility | The test article showed "negative" systemic toxicity. | Under the conditions of the study, the test article showed "negative" systemic toxicity. |
| ISO 10993-10 (Irritation) | Evaluate the endpoint of irritant for biocompatibility | The response of the test article has no skin irritation. | Under the experimental conditions, the test article has no skin irritation on rabbits. |
| ISO 10993-10 (Sensitization) | Evaluate the endpoint of sensitization for biocompatibility | The test article showed no evidence of causing delayed dermal contact sensitization. | The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For "Freedom from holes" (ASTM D5151), the results state "No water leakage is inspected from 200 samples."
- For other tests (powder residue, physical properties, dimensions, biocompatibility), specific sample sizes are not explicitly stated in the summary tables, beyond what would typically be required by the respective ASTM/ISO standards.
- Data Provenance: Not specified in the provided document. It implicitly refers to non-clinical bench testing and in vivo animal biocompatibility studies rather than human clinical data or geographical data. The applicant is based in China, suggesting the testing might have been conducted there, but this is not confirmed.
- Retrospective or Prospective: Not applicable as these are bench and animal tests, not human studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the device is a medical glove, and "ground truth" as typically defined for AI/CADe (e.g., diagnostic accuracy) is not relevant for its performance evaluation for this 510(k) submission. The "ground truth" is based on the physical and chemical properties measured against established standards.
4. Adjudication method for the test set
- Not applicable for the reasons stated in point 3. The evaluation is based on objective measurements against predefined standard thresholds.
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 is a medical glove, not an AI/CADe system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical glove, not an AI/CADe system.
7. The type of ground truth used
- The "ground truth" for the device's performance is established by objective measurements and results from standardized non-clinical tests (per ASTM and ISO standards) and animal biocompatibility studies, comparing these results directly against the specified acceptance criteria within those standards. This process does not involve expert consensus in the diagnostic sense, pathology data, or outcomes data related to disease.
8. The sample size for the training set
- Not applicable. This is a medical glove, not an AI/CADe system; there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this type of device.
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(148 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
The provided document describes the acceptance criteria and the study that proves Daxwell, LLC's Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) meet those criteria, primarily through a comparison to a predicate device and adherence to established ASTM and ISO standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension | ASTM D 5250-06(Reapproved 2011) | |
| Length | ≥230mm | 232-240mm |
| Width (Small) | 80-90mm | 81-90mm |
| Width (Medium) | 90-100mm | 93-98mm |
| Width (Large) | 100-110mm | 102-109mm |
| Width (X-Large) | 110-120mm | 110-118mm |
| Thickness (Fingertip) | ≥0.05mm | 0.08-0.11mm |
| Thickness (Palm) | ≥0.08mm | 0.09-0.12mm |
| Physical Properties | ASTM D 5250-06(Reapproved 2011) | |
| Tensile strength (Before & After aging) | ≥11MPa | 15-20MPa |
| Elongated rate (Before & After aging) | ≥300% | 360-420% |
| Freedom from Pinholes | 21 CFR 800.20, ASTM D5250-06 (Reapproved 2011), ASTM D5151-06 (Reapproved 2011), Inspection Level I AQL2.5 | Passed Standard (Waterleak test), Meets ASTM D5151-06 (Reapproved 2011) |
| Powder Residual | ASTM D 5250-06 (Reapproved 2011) and D6124-06 (Reaffirmation 2011) | Meets <2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10: 2010-08-01) | Passes (Not a Primary Skin Irritation) |
| Dermal sensitization in the guinea pig (ISO 10993-10: 2010-08-01) | Passes (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, dimensions, or physical properties). It refers to adherence to standards like ASTM D5250, ASTM D5151, ASTM D6124, 21 CFR 800.20, and ISO 10993-10, which would inherently include specified sampling plans for testing. However, the exact count of items tested via these standards is not provided.
The data provenance is not explicitly stated in terms of country of origin but is based on non-clinical performance data conducted to support a "substantial equivalence" determination. Given the submitter's address (Houston, TX, USA) and the Beijing agent's address (China), and the product's likely manufacturing location, it's probable the testing was conducted in facilities accustomed to these international standards. The data is retrospective, as it's being submitted for premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is typically not applicable to medical devices like examination gloves. The "ground truth" for these devices is established by adherence to recognized national and international standards (e.g., ASTM, ISO), which specify objective measurement methods and pass/fail criteria. There are no human experts "establishing ground truth" in the way one might for diagnostic imaging interpretation.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the assessment relies on objective measurements against predefined standards. There is no subjective human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is designed for evaluating the performance of diagnostic devices, often involving human readers interpreting medical images or data. This is not relevant for examination gloves, which are physical barrier devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a conceptual sense. The "standalone" performance here refers to the device itself meeting the objective physical, chemical, and biological criteria outlined in the standards, without human interaction influencing the test outcome or interpretation beyond standard lab procedures. The device's performance is assessed purely on its intrinsic properties.
7. The Type of Ground Truth Used
The ground truth used is primarily objective performance standards from recognized bodies:
- ASTM (American Society for Testing and Materials) standards: D5250 (Vinyl Patient Examination Gloves), D5151 (Detection of Holes in Medical Gloves), D6124 (Residual Powder on Medical Gloves).
- 21 CFR 800.20: FDA regulation concerning medical gloves.
- ISO 10993-10: Biological evaluation of medical devices - Tests for irritation and skin sensitization.
The "ground truth" is that if the glove meets the specified numerical/qualitative criteria (e.g., tensile strength ≥11MPa), then it performs as expected for its intended use.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its performance is based on manufacturing processes and adherence to quality control measures, which are then verified through testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as point 8.
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