(44 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.
Class 1 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.
The provided documentation describes the acceptance criteria and performance of the "Cashmere Non-Sterile, Polymer Coated Powder Free Latex Examination Gloves." This is a Class I medical device, and the evaluation is based on established ASTM standards and FDA requirements for such gloves, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (e.g., test set sample size, expert ground truth, MRMC study, standalone performance, training set) are not applicable.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D3578-95 & FDA) | Reported Device Performance (Cashmere Polymer Coated Powder Free Latex Exam Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | G I, AQL=4.0% | Pass GI, AQL=4.0% |
| 2. Length (mm) | Min 230 mm (all sizes) | 240 mm minimum for all sizes |
| - Size XS | Min 230 | 240 mm |
| - Size S | Min 230 | 240 mm |
| - Size M | Min 230 | 240 mm |
| - Size L | Min 230 | 240 mm |
| - Size XL | Min 230 | 240 mm |
| 3. Palm width (mm) | ||
| - Size XS | - | 75 - 78 |
| - Size S | 80 +/- 10 | 82 - 88 |
| - Size M | 95 +/- 10 | 92 - 98 |
| - Size L | 111 +/- 10 | 102 - 108 |
| - Size XL | - | 111 - 115 |
| 4. Thickness (mm) | ||
| - Finger (Single Layer) | Min 0.08 | 0.10 minimum |
| - Palm (Single Layer) | Min 0.08 | 0.10 minimum |
| 5. Physical Properties | ||
| Before Aging | ||
| - Tensile Strength (Mpa) | Min 14 | 16.5 |
| - Ultimate Elongation (%) | Min 700 | 550 |
| After Aging | ||
| - Tensile Strength (Mpa) | Min 14 | 23.1 |
| - Ultimate Elongation (%) | Min 500 | 520 |
| 6. Powder Content | - (No specific ASTM value provided) | Below 2 mg / glove |
| 7. Protein Content | - (No specific ASTM value provided) | Below 70 microgram / gram |
2. Sample size used for the test set and the data provenance
The document states that performance data is based on "ASTM D3578-95 and FDA 1000 ml watertight test." These standards specify sampling plans (e.g., AQL for watertightness), but the exact sample sizes used for this specific submission are not explicitly provided in the excerpt. The data provenance is for a manufacturing company located in Malaysia (SEAL POLYMER INDUSTRIES SDN. BHD., Lot 72706, Jalan Lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak, Malaysia). The nature of these tests (physical and chemical properties) indicates a prospective evaluation of manufactured samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical glove, and its performance is evaluated against objective physical and chemical standards (ASTM D3578-95, FDA watertight test). It does not involve expert interpretation or ground truth establishment in the context of diagnostic AI/ML devices.
4. Adjudication method for the test set
Not applicable. Device performance is measured against quantifiable standards for physical and chemical properties.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device's performance is objective measurement against established industry and regulatory standards. For example, for "Watertightness," the ground truth is whether the glove passes the FDA's 1000 ml watertight test at an AQL of 4.0%. For dimensions, it's the measured length and width compared to the specified range. For physical properties, it's the measured tensile strength and elongation compared to minimum requirements.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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.