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510(k) Data Aggregation
(153 days)
The Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) 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, Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) are disposable devices 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 includes variations of different size and color. The color of the proposed device is Blue and Purple-Blue. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for Disposable Nitrile Examination Gloves.
Important Note: This document pertains to the clearance of a medical device – specifically disposable nitrile examination gloves. The concepts of "AI models," "human readers," "effect size," "multi-reader multi-case (MRMC) comparative effectiveness studies," "standalone algorithms," and "ground truth establishment for training sets" as typically applied to AI/ML medical devices do not apply to this product. This submission focuses on the physical and performance characteristics of the gloves themselves compared to a predicate device.
Therefore, the answers to several of your requested points will be "Not Applicable" or refer to standard laboratory testing rather than AI/ML model validation.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue)
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Worst Case/Representative) |
|---|---|---|---|
| ASTM D5151 | Freedom from Holes | AQL 2.5 | Blue Color: No water leakage inspected from 200 samples (Meets AQL 2.5)Purple-Blue Color: No water leakage inspected from 200 samples (Meets AQL 2.5) |
| ASTM D6124 | Residual Powder for Powder-Free Gloves | <2.0 mg per glove | Blue Color: Avg. 0.29 mg (XS), 0.32 mg (S), 0.39 mg (M), 0.34 mg (L), 0.38 mg (XL)Purple-Blue Color: Avg. 0.33 mg (XS), 0.32 mg (S), 0.32 mg (M), 0.37 mg (L), 0.38 mg (XL)(All values are significantly less than 2.0 mg/glove) |
| ASTM D412, D573 | Physical Property Characteristics | Before Aging: Tensile Strength: ≥ 14 MPa, Ultimate Elongation: ≥ 500%After Aging: Tensile Strength: ≥ 14 MPa, Ultimate Elongation: ≥ 400% | Blue Color: Before Aging: Tensile Strength: ≥ 19 MPa, Ultimate Elongation: ≥ 500%. After Aging: Tensile Strength: ≥ 17.8 MPa, Ultimate Elongation: ≥ 472%.Purple-Blue Color: Before Aging: Tensile Strength: ≥ 19 MPa, Ultimate Elongation: ≥ 500%. After Aging: Tensile Strength: ≥ 17.1 MPa, Ultimate Elongation: ≥ 463%.(All values exceed the minimum acceptance criteria) |
| ASTM D412, D3767 | Physical Dimensions Specification | Length: ≥ 220 mm (XS, S), ≥ 230 mm (M, L, XL)Width: 70±10 mm (XS), 80±10 mm (S), 95±10 mm (M), 110±10 mm (L), 120±10 mm (XL)Cuff Thickness: ≥0.05 mm; Finger Thickness: ≥0.05 mm; Palm Thickness: ≥0.05 mm. (All meet ASTM D6319 requirements) | Blue Color (Representative for XS): Length: ≥ 230 mm; Width: 75±3 mm (75-78 mm); Cuff/Palm/Finger Thickness: ≥0.06 mm/≥0.07 mm/≥0.10 mm respectively.Purple-Blue Color (Representative for XS): Length: ≥ 230 mm; Width: 75±4 mm (75-79 mm); Cuff/Palm/Finger Thickness: ≥0.05 mm/≥0.07 mm/≥0.08 mm respectively.(All reported dimensions across all sizes and colors consistently meet or exceed the specified minimums and ranges) |
| ISO 10993-11 | Systemic Toxicity (Biocompatibility) | No evidence of systemic toxicity from the extract. | The test article showed no evidence of systemic toxicity from the extract. |
| ISO 10993-10 | Irritation (Biocompatibility) | The response of the test article extract is negligible. | The test result showed that the response of the test article extract was categorized as negligible under the test condition. |
| ISO 10993-10 | Sensitization (Biocompatibility) | 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 Data Provenance
- Sample Size for Physical/Performance Tests:
- Freedom from Holes (ASTM D5151): 200 samples were inspected for each color (Blue and Purple-Blue). This is per the standard's sampling requirements for AQL testing.
- Residual Powder (ASTM D6124): Quantities of powder were measured across various sizes (XS, S, M, L, XL) for both colors. The exact number of gloves per size/color tested isn't explicitly stated but would be based on the ASTM D6124 standard.
- Physical Property Characteristics (Tensile Strength, Elongation): Not explicitly stated, but standard test methods (ASTM D412, D573) specify the number of specimens to be tested per batch.
- Physical Dimensions: Not explicitly stated, but standard test methods (ASTM D412, D3767) specify the number of specimens to be measured.
- Biocompatibility Tests (ISO 10993-10, -11): These tests involve a specific number of animal subjects (e.g., guinea pigs for sensitization, mice for systemic toxicity, rabbits for irritation). The exact number isn't in the summary but is defined by the ISO standards.
- Data Provenance: The tests appear to be internal bench tests conducted by or for the manufacturer. No specific country of origin for the test data is given beyond the company's location (China). These are prospective tests performed specifically for this 510(k) submission, not retrospective data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. This is not an AI/ML device where "ground truth" is established by human experts reviewing medical images. The "ground truth" here is the objective measurement against established ASTM and ISO standards for physical properties, chemical residue, and biological safety of gloves. These measurements are performed by trained technicians in a laboratory setting, not by medical experts interpreting data like radiologists.
4. Adjudication Method for the Test Set
Not Applicable. As this is not an AI/ML device; there is no human interpretation or adjudication involved in the test results. The tests are objective measurements against pre-defined quantitative criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
Not Applicable. MRMC studies are used to assess the impact of AI on human reader performance, typically in imaging diagnostics. This device is a physical product (gloves) and does not involve human readers interpreting AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an algorithm or AI model. Its performance is measured directly through physical, chemical, and biological testing.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Reference Standards: Adherence to established and internationally recognized industry standards (ASTM D6319, D5151, D6124, ISO 10993-10, ISO 10993-11).
- Laboratory Measurements: Objective measurements of physical properties (e.g., length, width, thickness, tensile strength, elongation), chemical properties (residual powder), and biological responses (irritation, sensitization, systemic toxicity) using calibrated equipment and validated protocols.
8. The Sample Size for the Training Set
Not Applicable. This product is not an AI/ML model, and therefore, there is no "training set." The product's characteristics are inherent to its manufacturing process and materials, and its performance is validated through defined testing, not a learned model.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set for this type of device, this question is irrelevant.
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