(244 days)
Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Vinvl Blend Powder Free Examination Gloves (Black) are Patient Examination Gloves. Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. They are ambidextrous and come in different sizes-XS, S, M, L and XL. The physical and performance characteristics of the devices meet all requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided text is a 510(k) premarket notification for Nitrile Vinyl Blend Powder Free Examination Gloves (Black). This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and does not involve AI or algorithms, human readers, or clinical performance data in the context of medical image analysis or similar diagnostic applications.
Therefore, many of the requested categories are not applicable to this type of device and submission. Based on the provided text, here's the relevant information:
1. Table of acceptance criteria and the reported device performance
| Test method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Length | All size: Minimum 230mm | XS: 230-245mm |
| S: 230-245mm | |||
| M: 230-245mm | |||
| L: 230-245mm | |||
| XL: 230-247 mm | |||
| ASTM D6319-19 | Palm Width | XS: 70±10mm | |
| S: 80±10mm | |||
| M: 95±10mm | |||
| L: 110±10mm | |||
| XL: 120±10mm | XS: 76-78mm | ||
| S: 86-88 mm | |||
| M: 96-98mm | |||
| L: 106-110 mm | |||
| XL: 116-118 mm | |||
| ASTM D6319-19 | Thickness | Finger: 0.05mm (min) | |
| Palm: 0.05mm (min) | Finger: 0.06-0.08mm | ||
| Palm: 0.07-0.09mm | |||
| ASTM D6319-19 | |||
| ASTM D412-16 | Tensile Strength, Before Aging | 14MPa, min | 14.2-16.9 MPa |
| ASTM D6319-19 | |||
| ASTM D412-16 | Tensile Strength, After Accelerated Aging | 14MPa, min | 14.1-16.2MPa |
| ASTM D6319-19 | |||
| ASTM D412-16 | Ultimate Elongation, Before Aging | 500%, min | 500-520% |
| ASTM D6319-19 | |||
| ASTM D412-16 | Ultimate Elongation, After Accelerated Aging | 400%, min | 400-480% |
| ASTM D5151-19 | |||
| ASTM D6319-19 | Freedom from holes | G-I, AQL 2.5 | XS: 0/125 |
| S:0/125 | |||
| M: 0/125 | |||
| L:1/125 | |||
| XL: 1/125 | |||
| ASTM D6124-06(2017) | |||
| ASTM D6319-19 | Powder-Content | ≤ 2 mg per glove | XS:0.35mg |
| S: 0.41mg | |||
| M: 0.47mg | |||
| L: 0.55mg | |||
| XL: 0.66mg | |||
| ISO 10993-10:2010 | Skin Irritation Study | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant |
| ISO 10993-10:2010 | Maximization Sensitization Study | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO 10993-5:2009 | Cytotoxicity Test | Under the conditions of this study, the test article extract showed potential toxicity | Under the conditions of this study, the test article extract showed potential toxicity |
| ISO 10993-11:2017 | Systemic toxicity | Under the conditions of this study, there was no evidence of systemic toxicity. | Under the conditions of this study, there was no evidence of systemic toxicity. |
2. Sample size used for the test set and the data provenance:
- Freedom from holes: For each size (XS, S, M, L, XL), a sample size of 125 gloves was used.
- Powder-Content: Not explicitly stated, but results are given for each size.
- For other physical and biocompatibility tests, specific sample sizes are not detailed in the provided summary, but the tests were conducted.
- Data provenance: Not specified, but the product owner is Grand Work Plastic Products Co., Ltd. from China, suggesting the tests were likely conducted on products manufactured in China. The study is retrospective as it refers to completed tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. The device is an examination glove, and its performance is evaluated against established material and biocompatibility standards (e.g., ASTM, ISO), not by expert interpretation of clinical images or data requiring ground truth establishment by medical experts.
4. Adjudication method for the test set:
Not applicable, as this is for the evaluation of a physical medical device against a set of standards, not an AI or diagnostic algorithm requiring adjudication of interpretations.
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 submission is for a physical medical device (examination gloves), not an AI-powered diagnostic tool, and therefore no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithmic device.
7. The type of ground truth used:
The "ground truth" for this device is derived from established international standards for physical properties (e.g., tensile strength, dimensions, freedom from holes, powder content) and biological safety (biocompatibility tests for irritation, sensitization, cytotoxicity, systemic toxicity). These standards define the acceptable range or criteria for the device's performance.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.