(562 days)
- The chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.
Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| TEST | Acceptance Criteria (ASTM D 3578-91 & FDA 1000 ml watertight test) | Reported Device Performance (ONCOLOGY PLUS Powder Free Latex Examination Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 1.5 |
| 2. Length (mm) | ||
| Size S | min 230 | 295 |
| Size M | min 230 | 293 |
| Size L | min 230 | 298 |
| 3. Palm width (mm) | ||
| Size S | 80 ± 10 | 83 |
| Size M | 95 ± 10 | 94 |
| Size L | 111 ± 10 | 106 |
| 4. Thickness (mm) | ||
| Finger | min 0.08 | 0.27 |
| Palm | min 0.08 | 0.17 |
| 5. Physical Properties | ||
| Before Ageing : | ||
| Tensile Strength (MPa) | min 21 | 25.48 |
| Ultimate Elongation (%) | min 700 | 856 |
| After Ageing : | ||
| Tensile Strength (MPa) | min 16 | 20.81 |
| Ultimate Elongation (%) | min 500 | 969 |
| 6. Powder Content | - (No specific ASTM D 3578-91 criteria listed in this table) | below 2 mg / glove |
| 7. Moisture Content | - (No specific ASTM D 3578-91 criteria listed in this table) | max 0.8% / glove |
| 8. Protein Content | - (No specific ASTM D 3578-91 criteria listed in this table) | below 50 microgram / gram |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each test. However, it references ASTM D 3578-91 and FDA 1000 ml watertight test, which are standard specifications for latex examination gloves and often include sampling plans (e.g., AQL for watertightness). For the watertight test, an "AQL of 1.5" is mentioned, implying a sampling plan was followed.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the study was conducted by WEMBLEY RUBBER PRODUCTS (M) SDN BHD in Malaysia, suggesting the data was generated in Malaysia. Given that these are performance tests of a manufactured product, they are typically prospective in nature, performed on a batch of gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or diagnostic studies. The "ground truth" here is objective physical and chemical measurements (e.g., length, thickness, tensile strength, protein content) as defined by established standards like ASTM D 3578-91 and the FDA watertight test. These standards themselves are developed by expert consensus in their respective fields.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study that involves human interpretation or diagnosis requiring adjudication. The tests involve objective measurements against predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This document describes the performance testing of a medical device (examination gloves) against established physical and chemical standards, not a diagnostic or interpretative AI system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No, this is not an algorithm, but a physical product. The tests conducted are standalone in the sense that they evaluate the glove's intrinsic properties without human interaction beyond the testing procedure itself.
7. The Type of Ground Truth Used:
The ground truth used is based on:
- Standardized Specifications: Specifically, the requirements outlined in ASTM D 3578-91 for latex examination gloves.
- Regulatory Requirements: The FDA 1000 ml watertight test requirement.
- Manufacturer's Claims: For powder, moisture, and protein content, the manufacturer established target levels (e.g., "below 2 mg / glove" for powder content). These claims are validated by testing.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI study that involves a "training set." The tests are evaluating the physical properties of a manufactured product.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in this context.
§ 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.