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510(k) Data Aggregation
(95 days)
A disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
The proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is NBR BLUE 7214 (which composed of Phthalocyanine blue (CAS No.147-14-8) and Propylene glycol (CAS No.57-55-6). The examination glove is smooth surface with textured fingertips and a rolled rim atthe cuff edge.
The examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This document is a 510(k) Pre-Market Notification for "Nitrile Gloves (Model: NE01)". It does not describe an AI medical device. Therefore, many of the requested fields are not applicable.
Here's the information extracted from the provided text, focusing on the device's acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Test Purpose | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test | To determine the width, length, and thickness of the gloves | Width: For M: 95 ± 10mm For L: 110 ± 10mm For XL: 120 ± 10mm Length: For M: ≥230mm For L: ≥230mm For XL: ≥230mm Thickness: Finger: ≥0.05mm Palm: ≥0.05mm | Width: For M: 93 | Passed |
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Properties Test | To determine the tensile strength and ultimate elongation before and after acceleration aging | Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500% After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400% | Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500% After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400% | Passed |
| ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 2.5 | Pass at AQL 2.5 | Passed |
| ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | < 2.0 mg/glove | For M: Pass at 0.46 mg/glove For L: Pass at 0.52 mg/glove For XL: Pass at 0.14 mg/glove | Passed |
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To evaluate the potential intracutaneous reactivity caused by intracutaneously inject the extract to rabbits | Under the conditions of study not an irritation | Under the conditions of the study not a sensitization | Passed |
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To determine the skin sensitization potential in guinea pigs. | Under the conditions of the study not a sensitization | Under the conditions of study not an irritation | Passed |
| ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for acute systemic toxicity | The test item was evaluated for acute systemic toxicity in ICR mouse | Under the conditions of the study no systemic toxicity | Under the conditions of the study no systemic toxicity | Passed |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for dimensions, tensile strength, or holes). However, the tests reference ASTM and ISO standards, which typically specify sample sizes for their methodologies. The data provenance is implied to be from laboratory testing performed on the "Nitrile Gloves (Model: NE01)" manufactured by BYD Auto Industry Company Limited, based on the context of a 510(k) submission. It is a retrospective study since the tests were conducted prior to submission. The country of origin of the data is not explicitly stated beyond the manufacturing location in China.
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, not an AI-powered diagnostic device. The "ground truth" for these tests is based on objective measurements and established standards (ASTM, ISO), not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. The tests involve objective measurements against predefined criteria, not subjective interpretations 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 is a non-AI medical device (nitrile gloves).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-AI medical device (nitrile gloves).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests on the nitrile gloves is based on:
- Physical measurements: Dimensions (width, length, thickness).
- Mechanical properties: Tensile strength and ultimate elongation before and after aging.
- Defect detection: Freedom from holes (water tight test).
- Chemical properties: Residual powder.
- Biocompatibility results: Skin sensitization, skin irritation, and acute systemic toxicity results (determined through biological assays).
These are objective, quantifiable standards as defined by ASTM D6319-19 and ISO 10993 series.
8. The sample size for the training set:
Not applicable. This is a non-AI medical device; there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. This is a non-AI medical device; there is no "training set" or ground truth associated with it in the context of an AI algorithm.
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