(65 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 patient.
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA Water leak test.
Here's a breakdown of the acceptance criteria and study information for the Green Prospect Sdn Bhd Non-Sterile Powder Free, Latex Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D3578-01 & FDA) | Reported Device Performance | Comments |
|---|---|---|---|
| Pinhole (Watertightness) | AQL = 2.5 (1000ml) | Pass GI, AQL = 2.5 | Meets standard |
| Length (mm) | Min 220 (XS, S), Min 230 (M, L) | 240 mm minimum for all sizes | Exceeds standard |
| Palm Width (mm) | 70 ± 10 (XS), 80 ± 10 (S), 95 ± 10 (M), 111 ± 10 (L) | 73 - 78 (XS), 83 - 88 (S), 93 - 98 (M), 103 - 107 (L) | Within specified ranges |
| Thickness (mm) | |||
| (Single Layer) | Finger: Min 0.08 | ||
| Palm: Min 0.08 | Finger: Min 0.10 | ||
| Palm: Min 0.10 | Exceeds standard | ||
| Physical Properties (Before Aging) | Tensile Strength (MPa): Min 18 | ||
| Ultimate Elongation (%): Min 650 | |||
| Stress at 500% Elongation: Max 5.5 | Tensile Strength (MPa): 22 - 24 | ||
| Ultimate Elongation (%): 820 - 900 | |||
| Stress at 500% Elongation: 2.2 - 2.9 | Exceeds/meets standard | ||
| Physical Properties (After Aging) | Tensile Strength (MPa): Min 14 | ||
| Ultimate Elongation (%): Min 500 | Tensile Strength (MPa): 22 - 24 | ||
| Ultimate Elongation (%): 800 - 860 | Exceeds standard | ||
| Powder Content | Max 2.0 mg/glove | Below 2 mg/glove | Meets standard |
| Protein Content | Max 50 micrograms/gram | Below 50 micrograms/gram | Meets standard |
| Biocompatibility | Pass Primary Dermal Irritation Test, Pass Guinea Pig Sensitization (Buehler) test | Pass Biocompatibility Test | Meets standard |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. However, it references ASTM D3578-01, which is a standard specification for rubber examination gloves. This standard outlines procedures for sampling and testing. For example, for watertightness, it specifies an Acceptance Quality Limit (AQL) of 2.5, which implies a sampling plan where a certain number of gloves are tested from a lot, and the number of failures must not exceed a specified threshold for the lot to be accepted.
The data provenance is from Green Prospect Sdn Bhd, Malaysia. The studies appear to be retrospective in the sense that the data presented are the results of tests already conducted to demonstrate compliance with existing standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable in this context. The "ground truth" for medical gloves is established by predefined ANSI/ASTM and FDA standards and requirements, not through expert consensus on qualitative assessments. The tests are objective measurements against these established quantitative limits.
4. Adjudication Method for the Test Set
This is not applicable. The tests performed on medical gloves are objective and quantitative measurements (e.g., length, thickness, tensile strength, protein content). The results are compared directly to the numerical acceptance criteria defined in the relevant standards (ASTM D3578-01 and FDA requirements). There is no subjective interpretation requiring an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. MRMC studies are used to evaluate the diagnostic accuracy of imaging or other interpretive devices, often with and without AI assistance, comparing human reader performance. This device is a medical glove, and its performance is assessed through physical and chemical property testing, not through human interpretation of cases.
6. Standalone (Algorithm Only) Performance
This is not applicable. This device is a physical product (medical glove), not an algorithm or software. Its performance is inherent in its physical and chemical properties, measured directly through laboratory testing.
7. Type of Ground Truth Used
The ground truth used for evaluating the device is based on pre-established industry standards and regulatory requirements:
- ASTM D3578-01 Standard Specification for Rubber Examination Gloves
- FDA Pinhole Requirements
- FDA Minimum Powder Residual Content
- Label Claim of maximum 50 micrograms per gram of glove or less for water extractable protein.
- Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test).
8. Sample Size for the Training Set
This is not applicable. This device is a manufactured product (medical glove), not an AI/ML model or a diagnostic algorithm that requires a "training set" in the context of machine learning. The testing described is for product quality control and regulatory compliance.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons mentioned in point 8.
§ 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.