(133 days)
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Patient Examination Gloves (Yellow, White) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2015) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.
This document is a 510(k) Pre-Market Notification for Powder Free Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through clinical studies in the typical sense of AI/software devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" here refer to compliance with recognized standards and performance thresholds for examination gloves.
Here's a breakdown of the requested information based on the provided text, interpreted in the context of a medical glove submission:
1. A table of acceptance criteria and the reported device performance
| Testing Items | Acceptance Criteria (FDA-recognized Standard Requirements) | Reported Device Performance (Actual Testing Results) | Conclusion |
|---|---|---|---|
| Overall Length (mm) | 230 mm for all sizes minimum | S: 233-244mm, M: 231-241mm, L: 230-243mm, XL: 234-242mm | Pass |
| Width (mm) | S: 85±5, M: 95±5, L: 105±5, XL: 115±5 | S: 87-88 mm, M: 97-98 mm, L: 107-108 mm, XL: 118-119 mm | Pass |
| Palm Thickness (mm) | 0.08mm minimum | 0.08mm | Pass |
| Finger Thickness (mm) | 0.05mm minimum | 0.09-0.12mm | Pass |
| Tensile Strength (Mpa) - Before aging | 11Mpa minimum | 15.1-18.1Mpa | Pass |
| Tensile Strength (Mpa) - After aging | 11Mpa minimum | 14.9-17.7Mpa | Pass |
| Ultimate Elongation (%) - Before aging | 300% minimum | 390-470% | Pass |
| Ultimate Elongation (%) - After aging | 300% minimum | 380-490% | Pass |
| Pinhole | ASTM D 5250-06 (2015) requirements / Meet AQL 2.5 requirements | Meets AQL 2.5 requirements | Pass |
| Residual Powder | Not more than 2mg per glove | 0.18 mg/glove | Pass |
| Primary Skin Irritation Test | Under conditions of the study, not an irritant | Under conditions of the study, not an irritant | Pass |
| Dermal Sensitization Study | Under conditions of the study, not a sensitizer | Under conditions of the study, not a sensitizer | Pass |
| Cytotoxicity Test | Under the conditions of this study, not a cytotoxic potential | Under the conditions of this study, not a cytotoxic potential | Pass |
| Overall Performance | Meets ASTM D5250-06 (Reapproved 2015) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application | Conforms fully to ASTM D 5250-06 (2015) standard, applicable 21 CFR references, and FDA requirements | Overall Compliance Demonstrated |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The sample sizes are indicated by the "Inspection Level and AQL" (Acceptable Quality Limit) for most physical and performance tests, such as S-2, AQL4.0, and G-I, AQL2.5. For Residual Powder, the sample size was N=5. These AQL levels refer to sampling plans (e.g., ISO 2859-1 or ANSI/ASQ Z1.4), where a specific number of units are inspected from a lot, and the lot is accepted or rejected based on the number of defects found. The exact number of units tested isn't explicitly stated but would be determined by the AQL tables for the lot size.
- Data Provenance: The manufacturing entity is Shanxi Hongjin Plastic Technology Co., LTD, located in China. The testing would have been conducted by or on behalf of this company. The data is prospective in the sense that it's generated for the purpose of demonstrating compliance for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a medical device (patient examination gloves) tested against recognized physical, chemical, and biological standards. "Ground truth" in this context is established by the accepted scientific methodologies and criteria outlined in the ASTM and ISO standards, rather than expert human interpretation in the way it applies to diagnostic AI. Therefore, there are no "experts" in the sense of clinicians establishing ground truth for individual cases. The ground truth is the objective measurement against the specified standard requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image reading). For device performance testing against quantitative standards, the measurements are objective.
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 device is a physical product (medical glove), not an AI or software algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests in this submission is the objective measurement against scientifically established and recognized standards (e.g., ASTM D5250-06 for physical properties, specific thresholds for residual powder, and standard biocompatibility tests for irritation and sensitization). It is not pathology, outcomes data, or expert consensus on a diagnostic interpretation.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device, so there is no training set in that context. Statistical sampling is used for quality control during manufacturing and for conformity testing.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, this question is not relevant.
§ 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.