(291 days)
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Chienmax Vietnam Co. Ltd Powder Free Blue Nitrile Patient Examination Gloves are Class I disposable device which are made up of nitrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and which meets all of the requirements of ASTM standard D6319 00a (2005).
This document describes the Chienmax Vietnam Co. Ltd Powder-free Blue Nitrile Patient Examination Gloves and their substantial equivalence to predicate devices, rather than a clinical study evaluating the performance of an AI-powered medical device. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of acceptance criteria and the reported device performance
The acceptance criteria for the Chienmax Vietnam Co. Ltd Powder-free Blue Nitrile Patient Examination Gloves are based on meeting the requirements of ASTM standard D6319-00a (2005). The reported device performance indicates that the gloves meet these requirements.
| Characteristic and parameters | Acceptance Criteria (from ASTM D6319-00a and predicate) | Reported Device Performance (Chienmax) |
|---|---|---|
| Product Code | LZA | LZA |
| Intended Use | Prevent contamination between patient and examiner | Prevent contamination between patient and examiner |
| Width (size medium) | Approximately 89-98 (based on predicates) | 95 |
| Overall length | Approximately 240 (based on predicates) | 244 |
| Palm thickness | Min 0.08 - 0.12 (based on predicates) | 0.113 |
| Finger thickness | Min 0.08 - 0.148 (based on predicates) | 0.138 |
| Tensile strength pre aging min | 15 - 22 (based on predicates) | 16.78 |
| Tensile strength after aging min | 14 - 23.6 (based on predicates) | 17.40 |
| Ultimate elongation pre aging min | 500 - 679.4 (based on predicates) | 510 |
| Ultimate elongation after aging | 500 - 767.4 (based on predicates) | 555 |
| Biocompatibility | Yes (based on predicates) | Yes |
| Duration of biocompatibility | Limited (based on predicates) | Limited |
| Skin irritation test | Passes | Passes |
| Dermal sensitization | Passes | Passes |
| Residual powder test | Passes | Passes |
| Labeling | Identical to predicates (except for minor differences) | Minor Difference (from predicates) |
| Dermal Sensitization Test | Passes (implicit in biocompatibility) | Passes |
| Primary Skin irritation | Passes (implicit in biocompatibility) | Passes |
| Permeation testing per ASTM D 6978-05 | Passes | Passes |
| Iodine Test | Passes | Passes |
| Tensile strength | Meets ASTM D6319-00a requirements | Gloves meets the requirements of ASTM D6319-00a. |
| Barrier strength | Meets ASTM D6319-00a requirements | Gloves meets the requirements of ASTM D6319-00a. |
| Pinholes (AQL) | AQL 2.5 (from ASTM D6319-00a) | AQL 2.5 (Implicitly met as per "All testing meets requirements...") |
| Inspection level | S-2, AQL 4.0 (Physical specifications and dimensions) | S-2, AQL 4.0 (Implicitly met as per "All testing meets requirements...") |
2. Sample size used for the test set and the data provenance
The document mentions "Inspection level S-2, AQL 4.0, pinholes at AQL 2.5" for physical specifications and dimensions. This refers to acceptance sampling plans, but does not explicitly state the sample sizes used for each specific test. The data provenance is not specified beyond the fact that the manufacturer is in Vietnam. Given the context of a 510(k) summary for a glove, the testing would be prospective, conducted on manufactured batches of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is for a physical device (patient examination gloves) tested against established physical and chemical standards, not an AI device requiring expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable for this type of device and testing. The tests involve objective measurements and pass/fail criteria based on ASTM 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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used
The "ground truth" for this device is based on established industry standards (ASTM D6319-00a) for physical properties and performance (tensile strength, elongation, barrier strength, etc.), as well as biocompatibility testing to ensure safety (skin irritation, dermal sensitization).
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.
§ 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.