(88 days)
The Vinyl Glove is disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. The subject device is clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided text is a 510(k) Summary for a Vinyl Glove, which is a Class I medical device. This type of device does not typically involve complex algorithms or AI; instead, its performance is assessed against established physical and biocompatibility standards for medical gloves.
Therefore, the requested information regarding AI/algorithm performance, multi-reader multi-case studies, expert consensus for ground truth, and training set details are not applicable to this device submission. The "study" here refers to the non-clinical testing performed to demonstrate compliance with relevant standards.
Here's an analysis of the provided text in the context of the acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Test Method (Reference Standard) | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ISO 10993-10:2010 | To determine if device is a skin irritant | The device must be a non-irritant | Pass (Under the conditions of the study, not an irritant) |
| ISO 10993-10:2010 | To determine if device is a skin sensitizer | The device must be a non-sensitizer | Pass (Under conditions of the study, not a sensitizer) |
| ISO 10993-5:2009 | To determine if the device is potential toxicity to L-929 cells | The device must be a non-toxicity. | Pass (Under conditions of the study, did not show potential toxicity to L-929 cells) |
| ASTM D6124-06 (Reapproved 2017) | To determine residual powder | ≤ 2 mg/glove | Pass (Indicates it met the criterion; specific value not provided in the summary) |
| ASTM D5151-19 | To determine water tightness | Meet the requirements of ASTM D5151 AQL 2.5 | Pass (0/125 leaks) |
| ASTM D5250-19 | To determine physical dimensions | Length(mm): ≥230. | |
| Width(mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5. | |||
| Thickness (mm): Finger: ≥0.08; Palm: ≥0.08. | Length(mm): >230 (for all sizes S, M, L, XL). | ||
| Width(mm): S: 84-86; M: 95-97; L: 105-107; XL: 115-117. | |||
| Thickness (mm): Finger: 0.09-0.11; Palm: 0.08-0.11 (Note: These ranges appear to be for all sizes or representative of the range across sizes). All reported dimensions fall within the specified tolerances. Pass. | |||
| ASTM D412-06a-2013 | To determine physical properties (Tensile Strength & Ultimate Elongation) | Before Aging: Tensile Strength ≥11MPa; Ultimate Elongation ≥300%. | |
| After Aging: Tensile Strength ≥11MPa; Ultimate Elongation ≥300%. | Before Aging: Tensile Strength: 15.1~17.4 MPa; Ultimate Elongation: 552%~560%. | ||
| After Aging: Tensile Strength: 15.7~17.4 MPa; Ultimate Elongation: 527%~550%. All reported values for both before and after aging exceed the acceptance criteria. Pass. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- For "Freedom from Holes" (ASTM D5151-19): The test result states "0/125 leaks," implying a sample size of 125 gloves for this test.
- For other tests (Biocompatibility, Residual Powder, Physical Dimensions, and Physical Properties), specific sample sizes are not explicitly stated in this summary but are implied to be sufficient to establish compliance with the listed ASTM/ISO standards. These standards often specify minimum sample sizes for specific tests.
- Data Provenance: The document does not explicitly state the country of origin for the testing data. Given the manufacturer's location (Jiangsu, China) and the correspondent's location (Shanghai, China), it is highly probable that the testing was conducted in China.
- Retrospective or Prospective: This evaluation involves non-clinical laboratory testing of manufactured product samples. It is inherently prospective in the sense that the tests are performed on the device samples specifically for the purpose of demonstrating compliance for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable for this type of device (Vinyl Glove). "Ground truth" in the context of diagnostic AI/algorithms typically involves expert interpretation of medical images or clinical data. For a physical medical device like a glove, "ground truth" is established by adherence to globally recognized and validated laboratory testing standards (ASTM, ISO), using calibrated equipment and defined methodologies, rather than human expert interpretation of an outcome. The "experts" are the qualified laboratory technicians and scientists performing the tests according to the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in AI/algorithm studies where human readers are interpreting imaging or clinical data and their interpretations need to be reconciled to form a consensus "ground truth." For laboratory testing of a physical product, the test results are objective measurements or categorical outcomes (e.g., pass/fail for irritation), not subjective interpretations requiring adjudication.
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
This is not applicable. MRMC studies are conducted for diagnostic AI/imaging devices to assess how the AI assists human readers in making diagnoses. The Vinyl Glove is a Class I physical barrier device, not a diagnostic device with an AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. There is no algorithm or AI component in this device. Performance is tied to the physical and biocompatible properties of the glove material and manufacturing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on well-established international consensus standards and validated test methods (ASTM and ISO standards). These standards define the acceptable physical properties (e.g., tensile strength, dimensions, freedom from holes) and biological safety (biocompatibility) criteria for medical gloves. Compliance is determined by objective laboratory measurements and tests as defined by these standards.
8. The sample size for the training set
This is not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
§ 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.