(85 days)
The Vinyl patient examination glove, Powder Free, is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The proposed device, Vinyl patient examination glove, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The proposed is Powder Free Vinyl Patient Examination Gloves without color, and includes variations of different size.
The document describes a 510(k) premarket notification for a Vinyl Patient Examination Glove, Powder Free, and compares it to a predicate device. The information provided is primarily focused on demonstrating substantial equivalence based on physical properties, performance standards, and biocompatibility, rather than a clinical study evaluating a diagnostic or AI-powered device. Therefore, many of the requested categories related to AI/diagnostic device evaluation (e.g., human reader performance, effect size with AI assistance, training set details) are not applicable.
However, based on the provided text, I can extract the acceptance criteria and performance data related to the physical characteristics and safety of the glove.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criterion (Standard) | Proposed Device Performance | Predicate Device Performance | Remark/Compliance |
|---|---|---|---|---|
| Dimensions | ||||
| Length (S, M, L, XL) | ≥ 230 mm (min) - implied by ASTM D5250 compliance | 230 mm | 240 mm | SE (meets ASTM D5250) |
| Width (S, M, L, XL) | ± 5 mm (specific values not stated, but implied by ASTM D5250) | S: 85, M: 95, L: 105, XL: 115 (all ± 5 mm) | S: 85, M: 95, L: 105, XL: 115 (all ± 5 mm) | SE |
| Thickness (Finger) | ≥ 0.05 mm (min) (ASTM D5250) | ≥ 0.05 mm | 0.10 mm | SE (meets ASTM D5250) |
| Thickness (Palm) | ≥ 0.08 mm (min) (ASTM D5250) | 0.08 mm | 0.08 mm | SE (meets ASTM D5250) |
| Physical Properties (Before Aging) | ||||
| Tensile Strength | 11 MPa, min (ASTM D5250) | 11 MPa, min | 13 MPa, min | SE (meets ASTM D5250) |
| Ultimate Elongation | 300 % min (ASTM D5250) | 300 % min | 400 % min | SE (meets ASTM D5250) |
| Physical Properties (After Aging) | ||||
| Tensile Strength | 11 MPa, min (ASTM D5250) | 11 MPa, min | 13 MPa, min | SE (meets ASTM D5250) |
| Ultimate Elongation | 300 % min (ASTM D5250) | 300 % min | 400 % min | SE (meets ASTM D5250) |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 | Be free from holes when tested in accordance with ASTM D5151 | Be free from holes when tested in accordance with ASTM D5151 | SE |
| Powder Content | 0.50 mg per glove (ASTM D6124 and ASTM D5250) | 0.50 mg per glove | Meets ASTM D5250 requirements (specific value not given) | SE |
| Biocompatibility - Irritation | Not an irritant (ISO 10993-10) | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant | SE (Comply with ISO 10993-10) |
| Biocompatibility - Sensitization | Not a sensitizer (ISO 10993-10) | Under conditions of the study, not a sensitizer | Under conditions of the study, not a sensitizer | SE (Comply with ISO 10993-10) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document references standards like ASTM D5151 and ISO 2859-1 for sampling procedures, but it does not explicitly state the specific number of gloves tested for each criterion in this submission. ISO 2859-1 provides "Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection," meaning the actual sample size would depend on the lot size and the AQL specified for each test.
- Data Provenance: The tests were conducted by the manufacturer, Xingyuan Plastic Products Co., Ltd., which is located in TangShan City, Hebei PROV., China. The document does not specify if the testing was performed on a sample from a specific country of origin, but it is implied to be from the manufacturer's production. The study is a retrospective bench test comparison for regulatory 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 a submission for a medical device (glove) based on physical and material properties, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is defined by meeting established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No human adjudication is involved for physical property testing of a glove. The testing involves standardized laboratory methods.
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 not an AI-powered diagnostic tool, and no human reader study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is defined by industry standards and specifications (e.g., ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10) for physical properties, performance, and biocompatibility of medical examination gloves. Compliance with these standards serves as the benchmark.
8. The sample size for the training set
Not applicable. This refers to a manufactured product and its testing, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.