(14 days)
A 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.
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
Here is an analysis of the provided information regarding the acceptance criteria and the study for the device:
Device Name: POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
510(k) Number: K023590
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D3578-01/AE2 & FDA 1000ML watertight test) | Reported Device Performance (EVERGREEN POWDERED LATEX EXAM. GLOVES) |
|---|---|---|
| 1. Watertight (1000ml) | Multiple Normal GI, AQL = 2.5 | Pass GI, AQL = 2.5 |
| 2. Length (mm) | Min 220 (XS, S), Min 230 (M, L) | 240 mm minimum for all sizes |
| 3. Palm width (mm) | 70 ± 10 (XS), 80 ± 10 (S), 95 ± 10 (M), 111 ± 10 (L) | 73 - 78 (XS), 83 - 88 (S), 93 - 98 (M), 103 - 107 (L) |
| 4. Thickness (mm) (Single Layer) | ||
| Finger | Min 0.08 | Min 0.10 |
| Palm | Min 0.08 | Min 0.10 |
| 5. Physical Properties Before Aging | ||
| Tensile Strength (MPa) | Min 18 | 23 - 27 |
| Ultimate Elongation (%) | Min 650 | 820 - 880 |
| Stress at 500% Elongation | Max 5.5 | 2.9 - 3.6 |
| 6. Physical Properties After Aging | ||
| Tensile Strength (MPa) | Min 14 | 20 - 27 |
| Ultimate Elongation (%) | Min 500 | 780 - 860 |
| 7. Powder Content | 10mg per square decimeter max | Below 10 mg per square decimeter |
| 8. Bio-Compatibility | Not specified (implied by listed tests) | Dermal Sensitization, Primary Skin Irritation (Successful Results) |
Study Information
The provided document describes performance testing conducted to demonstrate that the device meets established standards.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each specific test, but the "Watertight (1000ml)" test mentions "Multiple Normal GI AQL = 2.5," which refers to an Acceptance Quality Limit sampling plan. This implies a statistical sampling method was used based on the AQL, but the exact number of units sampled is not provided.
- Data Provenance: The manufacturer is YTY INDUSTRY (MANJUNG) SDN BHD, suggesting the data originates from testing conducted by or for this Malaysian company. The document does not specify if the data is retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the study involves objective physical and chemical performance tests of latex gloves, not diagnostic interpretation or clinical assessment by experts. The "ground truth" is defined by the technical specifications and standard requirements (e.g., watertight, length, tensile strength).
4. Adjudication method for the test set:
- This information is not applicable for these types of performance tests. Adjudication methods are typically used when there are subjective interpretations or conflicting expert opinions, which is not the case for physical property measurements or watertight tests.
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 information is not applicable. The device is Latex Exam Gloves, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device is a physical product (latex gloves), not an algorithm or software.
7. The type of ground truth used:
- The ground truth is based on objective technical standards and measurements. Specifically, the listed ASTM standards (ASTM D3578-01/AE2, ASTM D5712-99, ASTM D6124-01, ASTM D5151-99), FDA watertight test (1000ML), ISO 2859, and established bio-compatibility tests (Dermal Sensitization, Primary Skin Irritation). These standards define the acceptable range or threshold for each performance characteristic.
8. The sample size for the training set:
- This information is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as 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.