(49 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Class 1 Powdered Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-99 and FDA Water Leak Test.
The provided text describes the acceptance criteria and performance data for "Cashmere Non-Sterile, Powdered Latex Examination Gloves". Here's the information requested, extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (based on ASTM D3578-99 and FDA 1000 ml watertight test) | Reported Device Performance (CASHMERE LIGHTLY POWDERED LATEX EXAM GLOVES) |
|---|---|---|
| 1. Watertight (1000 ml) | GI AQL=2.5% | Pass GI AQL=2.5% |
| 2. Length (mm) - All Sizes | Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm) - Size XS | - | 110 |
| 4. Thickness (mm) (Single Layer) - Finger | Min 0.08 | 0.10 minimum |
| 4. Thickness (mm) (Single Layer) - Palm | Min 0.08 | 0.10 minimum |
| 5. Physical Properties (Before Aging) - Tensile Strength (Mpa) | Min 14 | 27.1* |
| 5. Physical Properties (Before Aging) - Ultimate Elongation (%) | Min 700 | 917.5* |
| 5. Physical Properties (After Aging) - Tensile Strength (Mpa) | Min 14 | 24.9* |
| 5. Physical Properties (After Aging) - Ultimate Elongation (%) | Min 500 | 880* |
| 6. Powder Content | Below 200 mg / glove (FDA requirement) | Below 200 mg / glove |
| 7. Protein Content | Below 200 microgram / gram (As per the device name's claim) | Below 200 microgram / gram |
| 8. Biocompatibility Test | Pass Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test | Pass Biocompatibility Tests |
Note: The document states these figures were the average among the eight tested samples.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document explicitly mentions "eight tested samples" for the physical properties (tensile strength and ultimate elongation). For watertightness, it references "GI AQL=2.5%", which implies a sampling plan defined by ASTM D3578-99 and FDA 1000 ml watertight test, but the specific number of gloves tested is not provided in this summary.
- Data Provenance: The study appears to be retrospective, as it's a summary of performance data collected to demonstrate compliance with existing standards (ASTM D3578-99 and FDA requirements). The manufacturer is Seal Polymer Industries Sdn. Bhd., located in Lahat, Perak, Malaysia.
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 performance claim for a physical device based on standardized tests, not an AI/diagnostic device requiring expert ground truth establishment for medical image interpretation or similar. The "ground truth" is established by the specifications in ASTM D3578-99 and FDA requirements.
4. Adjudication method for the test set
Not applicable. As this involves physical testing against established standards, adjudication by experts for discordant results is not mentioned or typically relevant. The results are objective measurements or pass/fail criteria.
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 document describes a medical glove, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes a medical glove, not an algorithm.
7. The type of ground truth used
The ground truth for this device's performance is based on established industry standards and regulatory requirements:
- ASTM D3578-99 Standard
- FDA 1000 ml watertight test requirements
- FDA minimum powder residual content requirements
- Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test).
8. The sample size for the training set
Not applicable. This is a medical glove, not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical glove, not an AI device that requires a training set.
§ 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.