(60 days)
Xingyu Powder Free Nittile Patient Examination Gloves, White 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 the 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 D6319-10(Reapproved 2015) and ASTM D5151-06(Reapproved 2015).
The document describes the conformity of the Xingyu Nitrile Powder Free Patient Examination Gloves, White color to established standards for patient examination gloves. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, many of the requested elements (multi-reader multi-case study, AI-related information, expert qualifications, adjudication methods) are not applicable.
Here's the information that can be extracted and formatted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance | Result of Comparison (to Predicate) |
|---|---|---|---|
| Dimension | ASTM D6319-10(Reapproved 2015) | Meets ASTM D6319-10 (Reapproved 2015) | Same |
| Length | ≥230mm | ≥230mm min for all sizes (Subject Device: 232mm min for all sizes) | Same |
| Width (Small) | 70-90 mm | 80-88 mm | Same |
| Width (Medium) | 85-105mm | 89-102 mm | Same |
| Width (Large) | 100-120mm | 104-118mm | Same |
| Width (X Large) | 110-130 mm | 115-129 mm | Same |
| Thickness (Fingertip) | ≥0.05mm | ≥0.08mm | Same |
| Thickness (Palm) | ≥0.05mm | ≥0.08mm | Same |
| Physical Properties | ASTM D6319-10(Reapproved 2015) | Meets ASTM D6319-10 (Reapproved 2015) | Same |
| Tensile strength (Before aging) | ≥14MPa | 18-25 MPa | Same |
| Tensile strength (After aging) | - (Assumed to be ≥14MPa based on predicate) | 17-21 MPa | Same |
| Elongated rate (Before aging) | ≥500% | 560-600% | Same |
| Elongated rate (After aging) | ≥400% | 460-560% | Same |
| Freedom from Pinholes | • 21 CFR 800.20 | ||
| • ASTM D6319-10(Reapproved 2015) | |||
| • Test method in accordance with ASTM D5151-06(Reapproved 2015) | Passed Standard Acceptance Criteria | ||
| Tested in accordance with ASTM D5151 (Reapproved 2015) with acceptable results | Same | ||
| Powder Residual | ASTM D6319-10(Reapproved 2015) | ||
| Test method in accordance with D6124-06(Reaffirmation 2011) | |||
| Meets 0.1mg/glove (summary), Below 2mg of residual powder (comparison table) | Meets 0.1mg/glove | ||
| Results generated values below 2mg of residual powder | Same | ||
| Biocompatibility | ISO 10993-10: Third Edition 2010-08-01 (Primary Skin Irritation in rabbits, Dermal sensitization in the guinea pig) | Passes | |
| Not a Primary Skin Irritation | |||
| Not a Primary Skin Irritation | |||
| Under the conditions of this study, the test article was a non-irritant or non-sensitizer. (For both Skin Irritation and Dermal Sensitization Studies) | Same |
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 pinholes, or how many animals for biocompatibility). It generally refers to "bench testing."
- Data Provenance: The tests were conducted by Shandong Xingyu Gloves Co., Ltd (China). The data implicitly comes from internal testing by the manufacturer. It is retrospective as it was completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study involving ground truth established by human experts. The "ground truth" for these tests are the established ASTM and ISO standards for glove performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no expert adjudication process for these types of physical and chemical tests. The results are based on objective measurements against defined standards.
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 document is for patient examination gloves, not an AI or imaging device, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This document is for patient examination gloves, not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is objective measurement against pre-defined performance standards and regulatory requirements (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10, and 21 CFR 800.20 related to pinholes).
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. This is not a machine learning or AI device that requires a training set.
§ 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.