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510(k) Data Aggregation
(94 days)
The Nitrile Examination Glove (Powder free, 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, Nitrile Examination Glove (Powder free, 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. The color of the proposed device is Blue.
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
This document is a 510(k) Pre-market Notification for a medical device, specifically a Nitrile Examination Glove. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device. The information provided outlines the acceptance criteria and the results of non-clinical tests to prove the device meets these criteria.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5151 | Testing for Freedom from holes | Freedom from holes | No water leakage is inspected from 125 samples |
| ASTM D6124 | Determine the powder residue for powder free gloves | <2.0 mg per glove | Residual Powder: Average 0.1 Mg |
| ASTM D412, ASTM D573 | Testing for Physical property characteristics | Tensile Strength: 14 MPa min.Ultimate Elongation: 400% min. | Tensile Strength: ≥ 14 MPa;Ultimate Elongation: ≥ 400%. |
| ASTM D3767 | Testing For physical dimensions specification | Length: 230 mm min. for all size (S, M, L, XL);Width: 80±10 mm for S; 95±10 mm for M; 110±10 mm for L; 120±10 mm for XL.Finger Thickness: ≥0.05 mm;Palm Thickness: ≥0.05 mm;Cuff Thickness: ≥0.05 mm.All acceptance criteria above meet the requirements in Table 2 Dimensions and Tolerances of ASTM D6319 | Length of Size S: ≥ 254 mm; Width of Size S: 88±1 (87-89) mm; Palm Thickness of Size S: ≥0.07 mm; Finger Thickness of Size S: ≥0.12 mm.Length of Size M: ≥ 251 mm; Width of Size M: 96±2 (95-98) mm; Palm Thickness of Size M: ≥0.07 mm; Finger Thickness of Size M: ≥0.12 mm.Length of Size L: ≥ 255 mm; Width of Size L: 110±1 (109-111) mm; Palm Thickness of Size L: ≥0.07 mm; Finger Thickness of Size L: ≥0.12 mm.Length of Size XL: ≥ 244mm; Width of Size XL: 113±2 (111-115) mm; Palm Thickness of Size XL: ≥0.07 mm; Finger Thickness of Size XL: ≥0.12 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
- ASTM D5151 (Freedom from holes): 125 samples.
- Other tests (ASTM D6124, ASTM D412, ASTM D573, ASTM D3767, ISO 10993-11, ISO 10993-10): The specific sample sizes for these tests are not explicitly stated in the provided text beyond that they were sufficient to produce the reported results.
- Data Provenance: The origin of the test data (e.g., country of origin, retrospective/prospective) is not explicitly stated. The tests were performed as "bench tests" to verify design specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a medical glove, and the evaluation is based on objective physical, chemical, and biological performance tests against established standards, not on expert interpretations of data like in image analysis or diagnostic studies.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert interpretation. The tests described are objective measurements against predefined acceptance criteria.
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
No. This is a submission for a medical glove, not an AI-powered diagnostic device or a device requiring human reader interpretation. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a medical glove. Standalone performance refers to the performance of an algorithm without human intervention, which is not relevant for this device.
7. The type of ground truth used
The "ground truth" for the performance evaluation of this medical glove is established by objective performance specifications defined in recognized international standards:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-17 (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)
- ISO 10993-11:2017 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
The device's performance is compared against the quantitative and qualitative requirements set forth in these standards.
8. The sample size for the training set
This information is not applicable. A "training set" refers to data used to train machine learning models. This device is a physical product (a medical glove) and does not involve machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as #8.
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