(141 days)
A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.
Sunmax Enterprise Shanghai Co Powder free blue Nitrile Examination Glove is a class II device having product code 80LZA. It is a disposable device that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a patient examination glove, and its performance is assessed against established ASTM standards and specific physical characteristics. The document doesn't explicitly state "acceptance criteria" as a distinct section but lists characteristics and test results that imply acceptance based on meeting these values or passing these tests.
| Characteristic/Test | Acceptance Criteria (Implied by Predicate/Standard) | Reported Device Performance (Sunmax Device) |
|---|---|---|
| Physical Dimensions (Size Medium) | ||
| Width (size medium) | e.g., ~92mm (based on predicates) | 89mm |
| Overall length | 240mm (based on predicates) | 240mm |
| Palm thickness | e.g., ~0.17mm (based on predicates) | 0.12mm |
| Finger thickness | e.g., ~0.18mm (based on predicates) | 0.12mm |
| Mechanical Properties | ||
| Tensile strength pre-aging min | 21mpa (based on predicates for similar devices) | 18mpa |
| Tensile strength after-aging min | 16mpa (based on predicates for similar devices) | 18mpa |
| Ultimate elongation pre-aging min | 500 (based on predicates for similar devices) | 600 |
| Ultimate elongation after-aging min | 500 (based on predicates for similar devices) | 570 |
| Biocompatibility | ||
| Meets Biocompatibility | Yes (based on predicates) | Yes |
| Duration of biocompatibility | Limited (based on predicates) | Limited |
| Skin irritation test | Passes | Passes (Result of Primary Skin Irritation Test) |
| Dermal sensitization | Passes | Passes (Result of Dermal Sensitization Test) |
| Barrier Performance | ||
| Residual powder test | Passes | Passes |
| Permeation testing per ASTM D 6978-05 | Passes (Performance against specific chemotherapy drugs) | Passes (Table of breakthrough times for 9 chemo drugs) |
| Iodine Test | Passes | Passes |
| Barrier strength | Meets requirements of ASTM D6319-00a | Meets the requirements of ASTM D6319-00a |
| General Glove Requirements | ||
| Meets ASTM D 6319-00a-05 (overall standard) | Meets requirements | Gloves meets the requirements of ASTM D6319-00a (for tensile strength) and overall testing meets requirements |
| Inspection level, AQL (pinholes) | S-2, AQL 4.0, AQL 2.5 (pinholes) | (Implied by adherence to ASTM D6319-00a standards) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a separate "test set" sample size for the various tests. It generally refers to testing being conducted to meet ASTM standards. For pinholes and general inspection, it mentions "Inspection level S-2, AQL 4.0, pinholes at AQL 2.5," which are statistical sampling plans defined within the ASTM standard, but not explicit sample numbers.
- Data Provenance: Not explicitly stated. The manufacturer is in Shanghai, China, so it's most likely that the testing was performed there. It's retrospective in the sense that the data is presented as a summary of completed tests for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a medical glove, and "ground truth" as typically defined for diagnostic or AI-driven devices (e.g., expert consensus on images, pathology reports) is not relevant. The performance is assessed through standardized physical, chemical, and biological tests.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" are used for expert review where there might be disagreement, usually for image interpretation or similar qualitative assessments. For material property testing, the results are quantitative and objective measurements or pass/fail criteria against a standard.
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-driven device or a diagnostic device where human readers would be involved in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (glove), not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- ASTM Standard Specifications: Specifically, ASTM D 6319-00a-05 for physical properties and dimensions.
- Permeation Testing per ASTM D 6978-05: For chemotherapy drug resistance, the "ground truth" is whether the glove prevents breakthrough for a specified duration according to this standard.
- Biocompatibility Testing: "Passes" results for dermal sensitization and primary skin irritation tests establish the ground truth for biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is involved.
§ 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.