(29 days)
A patient examination glove 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.
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.
This document describes the acceptance criteria and the study conducted for "Cashmere Polymer Coated Powder Free Nitrile Examination Gloves".
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D6319-00aE3 / FDA) | Reported Device Performance (POLYMER COATED POWDER FREE NITRILE EXAM GLOVES) |
|---|---|---|
| Watertight (1000 ml) | AQL=2.5% Pass G I (ASTM D6319-00aE3) | AQL=2.5% Pass GI |
| Length (mm) | ||
| Min Length (all sizes) | Min 230 | 240 mm minimum for all sizes |
| Palm Width (mm) | ||
| Size XS | - (no specific ASTM value) | E3) |
| Biocompatibility Test | - (not specified in ASTM D6319-00aE3) | Pass (Primary Dermal Irritation Test, Guinea Pig Sensitization (Buehler) test) |
Note: The asterisk () indicates average results from Attachment C, which is not provided in the given document.*
Study Details:
This document is a 510(k) summary for medical gloves, which are considered Class I devices. The studies performed are primarily bench tests and material characterization, aligning with the regulatory requirements for such devices. The concept of "AI" or "algorithms" does not apply to this type of device.
2. Sample size used for the test set and data provenance:
- The document implies that testing was conducted on samples of the manufactured gloves to ensure they meet the specified standards. However, the specific sample sizes for each test (e.g., number of gloves for watertight test, length, width, thickness, tensile strength, elongation, powder content, and biocompatibility) are not explicitly stated in the provided text.
- The data provenance is from Seal Polymer Industries Berhad, Malaysia, presumably from their internal testing facilities. The tests are described as performance data of gloves, which indicates a prospective testing approach on manufactured products.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- This is not applicable as the device is a physical medical glove. The "ground truth" is established by adherence to recognized industrial standards (ASTM D6319-00aE3) and FDA requirements, rather than expert interpretation of complex data like medical images. The tests involve objective measurements and established protocols.
4. Adjudication method for the test set:
- This is not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in diagnostic or imaging studies. For physical product testing, results are determined by direct measurement against quantitative 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:
- This is not applicable. This is a physical medical device (examination gloves), not an AI/software device involving human readers or interpretation of cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is a physical medical device; there is no algorithm involved.
7. The type of ground truth used:
- The "ground truth" for the device's performance is based on established industrial standards (ASTM D6319-00aE3) and specific FDA requirements (e.g., watertight test, powder residual content, pinhole requirements, biocompatibility standards). These standards define the acceptable performance characteristics for patient examination gloves.
8. The sample size for the training set:
- This is not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI. The manufacturing process of the gloves would involve quality control and process validation, but not a "training set" in the computational sense.
9. How the ground truth for the training set was established:
- This is not applicable as there is no training set for this physical 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.