(49 days)
Xing Yu Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile films form a barrier to prevent contamination between patient and examiner. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151.
The provided document is a 510(k) Premarket Notification for a medical device (Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's clinical performance against detailed acceptance criteria in the context of, for example, an AI/ML diagnostic device.
Therefore, the specific information requested in your prompt regarding acceptance criteria and a study to prove the device meets them (especially points 2-9, which relate to diagnostic performance studies) is not applicable in the context of this document.
However, I can extract information related to the performance specifications used to demonstrate substantial equivalence of the gloves, which are akin to acceptance criteria based on established standards for medical examination gloves.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
The device's performance is measured against ASTM standards and FDA regulations for examination gloves. The "acceptance criteria" here are the requirements of these standards. The "reported device performance" indicates whether the device met these criteria.
| Characteristics | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension (Length) | ASTM D6319-10 (reapproved 2015): $\geq$ 230mm | $\geq$ 232mm (for all sizes) |
| Dimension (Width) | ASTM D6319-10 (reapproved 2015): Small 70-90mm, Medium 85-105mm, Large 100-120mm, XLarge 110-130mm | Small 76-88mm, Medium 89-102mm, Large 108-119mm, XLarge 115-128mm |
| Thickness (Fingertip) | ASTM D6319-10 (reapproved 2015): $\geq$ 0.05mm | $\geq$ 0.08mm |
| Thickness (Palm) | ASTM D6319-10 (reapproved 2015): $\geq$ 0.05mm | $\geq$ 0.08mm |
| Physical Properties (Tensile Strength Before Aging) | ASTM D6319-10 (reapproved 2015): $\geq$ 14MPa | 18-25MPa |
| Physical Properties (Tensile Strength After Aging) | ASTM D6319-10 (reapproved 2015): $\geq$ 14MPa | 17-22MPa |
| Physical Properties (Elongation Rate Before Aging) | ASTM D6319-10 (reapproved 2015): $\geq$ 500% | 530-600% |
| Physical Properties (Elongation Rate After Aging) | ASTM D6319-10 (reapproved 2015): $\geq$ 400% | 460-580% |
| Freedom from Pinholes | 21 CFR 800.20, ASTM D6319-10 (reapproved 2015) - Test method: ASTM D5151-06 (reapproved 2015) | Passed Standard Acceptance Criteria (Tested with acceptable results) |
| Powder Residual | ASTM D6319-10 (reapproved 2015) - Test method: D6124-06 (reaffirmation 2011): Meets 0.1mg/glove (equivalent to below 2mg of residual powder implied by predicate comparison) | Meets 0.1mg/glove (Results generated values below 2mg of residual powder) |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10: Third Edition 2010-08-01 (Not a primary skin irritant) | Passes (Not a primary skin irritant) |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10: Third Edition 2010-08-01 (Not a skin sensitizer) | Passes (Not a skin sensitizer) |
Non-Applicable Information for this Document:
The following points are typically relevant for diagnostic devices, especially those incorporating AI/ML. This 510(k) for examination gloves does not contain this type of information.
- Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing of physical properties and biocompatibility, not a test set of data for diagnostic performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic classifications is not established for this device.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not a diagnostic device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (gloves), not an algorithm.
- The type of ground truth used: Not applicable. The "ground truth" for gloves is adherence to material, physical, and biocompatibility standards.
- The sample size for the training set: Not applicable. There is no AI/ML training set for this device.
- How the ground truth for the training set was established: Not applicable.
§ 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.