(66 days)
The Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves 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.
Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a83 and FDA Water leak test.
Here's a breakdown of the acceptance criteria and the study details for the "NON-STERILE, ON-LINE POWDER-FREE, NITRILE BLUE & WHITE COLOR, EXAMINATION GLOVES," based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (ASTM D6319-00a83 & FDA) | Reported Device Performance |
|---|---|---|
| Watertight (1000ml) | AQL = 2.5 (Multiple Normal GI) | Pass GI (AQL = 2.5) |
| Length (mm) | Min 220 (XS, S) Min 230 (M, L) | 240 mm minimum for all sizes |
| Palm Width (mm) | XS: 70 ± 10; S: 80 ± 10; M: 95 ± 10; L: 111 ± 10 | XS: 73 - 78; S: 83 - 88; M: 93 - 98; L: 103 - 107 |
| Thickness (mm) (Single Layer) | Finger: Min 0.05; Palm: Min 0.05 | Finger: Min 0.15; Palm: Min 0.12 |
| Physical Properties (Before Aging) | ||
| - Tensile Strength (MPa) | Min 14 | 27 - 30 |
| - Ultimate Elongation (%) | Min 500 | 780 - 800 |
| Physical Properties (After Aging) | ||
| - Tensile Strength (MPa) | Min 14 | 25 - 27 |
| - Ultimate Elongation (%) | Min 400 | 670 - 730 |
| Powder Content | Max 2.0 mg/glove | Below 2 mg/glove |
| Biocompatibility | Pass Primary Dermal Irritation and Guinea Pig Sensitization (Buehler) | The gloves pass the Bio-compatibility Test (implied as meeting criteria) |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each test. The document refers to "Multiple Normal GI" for the watertight test, suggesting a sampling plan. However, the specific number of gloves tested for each individual parameter (length, width, thickness, tensile strength, etc.) is not provided.
- Data Provenance: The document does not specify the country of origin of the data. It is a submission by YTY Industry (Manjung) Sdn Bhd (Malaysia) to the FDA (USA). The testing itself would likely have been conducted at a laboratory associated with the manufacturer or a third-party testing facility. The nature of the study is retrospective in the sense that results are presented as already obtained data to demonstrate compliance with existing standards.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. This study primarily involves performance testing against engineering and material standards, not expert medical interpretation of images or patient conditions.
- Qualifications of Experts: Not applicable.
4. Adjudication Method
- Adjudication Method: Not applicable. This study relies on objective physical and chemical measurements rather than subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools where human readers interpret medical images. This document describes the performance of a medical device (examination gloves) based on established physical and chemical standards.
6. Standalone Performance Study
- Standalone Performance Study: Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently against predefined technical standards (ASTM D6319-00a83 and FDA requirements) without human intervention in the primary measurement process itself. The "algorithm" in this context is the glove itself, and its performance is measured directly.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this study is based on established industry standards and regulatory requirements.
- ASTM D6319-00a83 Standard: This is a recognized material specification standard for patient examination gloves.
- FDA 1000ML Watertight Test: A regulatory requirement specifically for medical gloves.
- FDA Requirements for Powder Content: A specific regulatory limit for powder residue.
- Biocompatibility Standards: Implicitly, the primary dermal irritation and sensitization tests are performed against predefined criteria for what constitutes a "pass."
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no "training set" in the context of this device study. This is not an AI/machine learning model that requires training data. The gloves are manufactured and then tested for compliance with specifications.
9. How Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of 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.