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510(k) Data Aggregation
(163 days)
Disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile Examination Gloves Powder Free (Blue) are available in blue color. The proposed device is single use, non-sterile, ambidextrous and meets all the requirements of ASTM Specification D6319-10 (2015) — Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Nitrile Examination Gloves Powder Free (Blue) product (K210868).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (and Standard) | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM D6319-10 (Reapproved 2015) | Determine length of the gloves | Length ≥ 230 mm for all sizes | Pass |
| ASTM D6319-10 (Reapproved 2015) | Determine width of the gloves | Size S – 85 ± 5 mm | |
| Size M – 95 ± 5 mm | |||
| Size L – 105 ± 5 mm | |||
| Size XL – 115 ± 5 mm | Pass | ||
| ASTM D6319-10 (Reapproved 2015) | Determine thickness of the gloves | Finger ≥ 0.05 mm | |
| Palm ≥ 0.05 mm for all sizes | Pass | ||
| ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves) | Determine holes in the gloves | Accept: 5 out of 125 pieces sample size | Pass |
| ASTM D6124-06 (Reapproved 2017, Standard Test Method for Residual Powder on Medical Gloves) | Determine residual powder in the gloves | ≤ 2 mg/glove | Pass (0.70 mg/glove) |
| ASTM D6319-10 (Reapproved 2015) | Determine physical properties - Tensile strength | Before aging ≥ 14 MPa | |
| After aging ≥ 14 MPa | Before aging: Average: 24.83 MPa, Median: 24.90 MPa | ||
| After aging: Average: 26.23 MPa, Median: 25.95 MPa | |||
| ASTM D6319-10 (Reapproved 2015) | Determine physical properties - Ultimate Elongation | Before aging ≥ 500 % | |
| After aging ≥ 400 % | Before aging: Average: 509.23 %, Median: 500 % | ||
| After aging: Average: 436.92 %, Median: 440 % |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Holes in Medical Gloves (ASTM D5151-19): An acceptance criterion of "5 out of 125 pieces sample size" is specified, implying a sample size of 125 pieces was used for this test.
- Sample Size for Residual Powder (ASTM D6124-06): While the acceptance criterion is ≤ 2 mg/glove, the specific sample size used for this test is not explicitly stated, only that the result was 0.70 mg/glove.
- Sample Size for other tests (Length, Width, Thickness, Physical Properties): The specific sample sizes for these tests are not explicitly mentioned in the provided text.
- Data Provenance: The studies were non-clinical performance tests conducted by Great Eco Glove Sdn. Bhd., a company located in Malaysia. The type of data is laboratory test results. The document does not specify if the data is retrospective or prospective, but given it's for a 510(k) submission, it would reflect tests performed on batches of the actual device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this device (nitrile examination gloves) relies on standardized objective measurements and chemical/physical properties as defined by ASTM and ISO standards, not expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements and adherence to specified ranges or limits outlined in the standards, rather than subjective interpretation requiring adjudication.
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 glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. As stated above, this device is a medical glove and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device is based on established industry standards and objective measurements. Specifically, the adherence to physical characteristics (length, width, thickness, tensile strength, ultimate elongation), absence of holes, and residual powder content are verified against the requirements set by:
- ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility)
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. It is a physical product whose performance is evaluated through non-clinical laboratory testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device. The "ground truth" for the device's performance is defined by the technical specifications and limits set forth in the aforementioned ASTM and ISO regulatory standards.
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