(39 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 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-00a and FDA Water Leak Test.
The provided document describes the acceptance criteria and performance data for Cashmere Powder Free Latex Examination Gloves.
1. Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D3578-00a) | Reported Device Performance (Cashmere Powder Free Latex Exam Gloves) |
|---|---|---|
| Watertight (1000 ml) | GI AQL=4.0% | Pass GI AQL=4.0% |
| Length (mm) | ||
| - Size XS | Min 230 | 240 mm minimum for all sizes |
| - Size S | Min 230 | |
| - Size M | Min 230 | |
| - Size L | Min 230 | |
| - Size XL | Min 230 | |
| 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 |
| Thickness (mm) | ||
| - Finger (Single Layer) | Min 0.08 | 0.10 minimum |
| - Palm (Single Layer) | Min 0.08 | 0.10 minimum |
| Physical Properties | ||
| - Before Aging | ||
| - Tensile Strength (Mpa) | Min 14 | 25.1 |
| - Ultimate Elongation (%) | Min 650 | 940 |
| - After Aging | ||
| - Tensile Strength (Mpa) | Min 14 | 18 |
| - Ultimate Elongation (%) | Min 500 | 950 |
| Powder Content | - | Below 2 mg / glove |
| Protein Content | - | Below 50 microgram / gram |
| Biocompatibility | - (implicitly, pass tests) | Pass Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test |
2. Sample size used for the test set and the data provenance
The document specifies "GI AQL=4.0%" for the watertight test, which refers to General Inspection Level 1 with an Acceptance Quality Limit of 4.0% according to ASTM D3578-00a. This standard typically involves sampling plans where the sample size is determined by the lot size, but the exact number of units tested is not explicitly stated in the provided text.
The data provenance is from Malaysia, specifically from SEAL POLYMER INDUSTRIES SDN. BHD. The study appears to be prospective as it involves the testing of a manufactured product against established standards.
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 document describes performance testing of a physical product (gloves) against established engineering and material standards (ASTM D3578-00a and FDA requirements), not the establishment of ground truth by human experts for a diagnostic algorithm.
4. Adjudication method for the test set
This information is not applicable as the document describes performance testing of a physical product against established objective standards, not a process requiring expert 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 information is not applicable as the document describes the performance of a physical medical device (examination gloves) and does not involve AI, human readers, or case studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document pertains to the performance of a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used consists of established industry standards and regulatory requirements:
- ASTM D3578-00a Standard for Latex Examination Gloves
- FDA Water Leak Test requirements (1000 ml watertight test)
- FDA minimum powder residual content requirements
- Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test)
8. The sample size for the training set
This information is not applicable. The document describes the performance of a physical product, not a statistical model or algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set mentioned or implied for this physical product performance testing.
§ 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.