(152 days)
Disposable device intended for medical purposes that is worn on the examiner's hand(s) or finger(s) to prevent contamination between patient and examiner.
Product is a light and flexible glove, in standard sizes, for use in examination procedures, sold non-sterile and intended to be disposed of after use with each patient.
Acceptance Criteria and Device Performance Study for CLK International Powder-Free Latex Examination Glove
This document outlines the acceptance criteria and the study performed to demonstrate that the CLK International Powder-Free Latex Examination Glove meets these criteria, based on the provided 510(k) summary (K974371).
1. Table of Acceptance Criteria and Reported Device Performance
The CLK International Powder-Free Latex Examination Glove is assessed against the requirements of ASTM D3578 voluntary standards for latex examination gloves, as well as biocompatibility test data as required by Int. Std ISO-10993 as modified by the FDA in the General Program Memorandum #G95-1.
| Acceptance Criteria Standard | Specific Test/Characteristic | Acceptance Criteria (from ASTM D3578 and ISO-10993) | Reported Device Performance | Comments |
|---|---|---|---|---|
| ASTM D3578 | Physical Characteristics (before aging) | Meets ASTM D3578 requirements | Meets ASTM D3578 requirements | (Details not explicitly provided in the summary but implied) |
| ASTM D3578 | Physical Characteristics (after aging) | Meets ASTM D3578 requirements | Meets ASTM D3578 requirements | (Details not explicitly provided in the summary but implied) |
| ASTM D3578 | Evaluation of Leakage | Meets ASTM D3578 requirements | Meets ASTM D3578 requirements | (Details not explicitly provided in the summary but implied) |
| ISO-10993 (modified by FDA G95-1) | Primary Dermal Irritation | Meets ISO-10993 requirements | Meets ISO-10993 requirements | (Details not explicitly provided in the summary but implied) |
| ISO-10993 (modified by FDA G95-1) | Maximization Sensitization | Meets ISO-10993 requirements | Meets ISO-10993 requirements | (Details not explicitly provided in the summary but implied) |
Note: The 510(k) summary states that "Characteristics of the CLK Int'l latex powder-free examination gloves are compared with ASTM D3578 in Attachment I, Table I" and "Tests show they meet the requirements of ASTM D3578 for latex examination gloves." However, the actual Attachment I, Table I, and detailed numerical results are not provided in the excerpt. Similarly, for biocompatibility, it states "biocompatibility test data as required by Int. Std ISO-10993 as modified by the FDA in the General Program Memorandum #G95-1," again without specific data points in the provided text.
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 (e.g., physical characteristics, leakage, biocompatibility). It only generally refers to "Tests" and "Test Data."
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It implies the data was collected specifically for the purpose of demonstrating equivalence, suggesting it was prospectively generated to meet the defined standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable in the context of this device. The ground truth for this device (a Class I medical device, examination glove) is established by adherence to recognized voluntary consensus standards (ASTM D3578) and international biocompatibility standards (ISO-10993 modified by FDA guidance), rather than expert consensus on medical images or clinical outcomes. The "experts" in this context would be the testing laboratories and their qualified personnel who perform the standardized tests according to the specified methodologies.
4. Adjudication Method for the Test Set
This information is not applicable. As the ground truth is based on objective, standardized test methods defined by ASTM and ISO, there is no need for expert adjudication methods (like 2+1 or 3+1 consensus) that are typically used for subjective assessments (e.g., medical image interpretation). The tests produce quantifiable results that either meet or do not meet the predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images) and the AI's impact on their performance is being evaluated. For a medical glove, performance is measured against physical and biological standards, not through human reader interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
This concept is not applicable to this device. A medical glove does not involve an algorithm or AI. Its performance is intrinsic to its physical and material properties.
7. The Type of Ground Truth Used
The ground truth used for this device is based on two main types:
- Standardized Performance Metrics: Defined by ASTM D3578 for physical characteristics (e.g., tensile strength, elongation, freedom from holes).
- Biocompatibility Standard Metrics: Defined by ISO-10993 (modified by FDA G95-1) for biological safety (e.g., dermal irritation, sensitization).
These are objective, quantifiable measures established by industry and regulatory bodies to ensure the safety and efficacy of medical gloves.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" is relevant for AI/ML algorithms where a model learns from data. A medical glove is a physical product, not an algorithm. Its properties are inherent to its manufacturing process and materials.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated above.
§ 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.