(93 days)
A powder-free 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
Latex Exam Gloves are formulated using Natural Rubber Latex. The device is offered powder-free and sterile.
This document describes the safety and effectiveness of "Sterile Latex Powder Free Exam Gloves" by Cardinal Health, submitted under 510(k) K081464. The purpose is to demonstrate substantial equivalence to a predicate device (Cardinal Health's Powder-Free Latex Exam Gloves, K024292).
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (from referenced ASTM/CFR/ISO standards) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | (Implied: Non-irritating, common biological safety requirement for medical devices in contact with skin) | Gloves are non-irritating. |
| Guinea Pig Maximization | (Implied: No potential for sensitization, common biological safety requirement) | Gloves do not display any potential for sensitization. |
| Ultimate Elongation | Requirements for latex exam rubber gloves per ASTM D 3578 | Gloves meet requirements for latex exam rubber gloves per ASTM D 3578 |
| Tensile Strength | Requirements for latex exam rubber gloves per ASTM D 3578 | Gloves meet requirements for latex exam rubber gloves per ASTM D 3578 |
| Barrier Defects (Permeation) | Requirements per 21 CFR Section 800.20 AQL = 4.0 and ASTM D 3578, AQL = 2.5. Cardinal Health internal AQL is 1.5. | Gloves meet requirements per 21 CFR Section 800.20 AQL = 4.0 and ASTM D 3578, AQL = 2.5. (Implied: And meet Cardinal Health internal AQL = 1.5 as it's a tighter standard) |
| Powder Level | Powder level requirements for "Powder Free" designation using ASTM Standard D 6124 (specifically, below 2 mg of residual powder per glove) | Results generated values below 2 mg of residual powder per glove. |
| Packaging Integrity | Requirements per ANSI, AAMI, ISO 11607-1, Part 1 (Packaging for terminally sterilized medical devices - Part1, requirements for materials, sterile barrier systems and packaging systems) AND ANSI, AAMI, ISO 11607-2, Part 2 (Packaging for terminally sterilized medical devices - part-2) | Packaging was tested (and implicitly meets the requirements) following ANSI, AAMI, ISO 11607-1 Part 1, and ANSI, AAMI, ISO 11607-2 Part 2. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for elongation, tensile strength, or barrier defects). The data provenance is internal to Cardinal Health, as indicated by "Cardinal Health internal AQL is 1.5" and "Results generated values below 2 mg of residual powder per glove." The tests are likely conducted on product batches as part of quality control and product validation.
- Country of Origin of the Data: Not explicitly stated, but assumed to be from Cardinal Health's manufacturing and testing facilities.
- Retrospective or Prospective: These tests are typically prospective, performed on manufactured products to ensure they meet specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (exam gloves) does not typically involve expert "ground truth" establishment in the medical imaging or diagnostic sense. The "ground truth" here is objective, measurable physical and chemical properties and biological safety assessments, measured against established industry standards (ASTM, ISO, CFR). The "experts" would be the personnel performing the laboratory tests (e.g., chemists, materials scientists, microbiologists, toxicologists) who are qualified to conduct these tests according to the specified standards, but their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective and based on established physical, chemical, and biological testing methods. There is no subjective interpretation requiring adjudication among multiple experts. The results are quantitative (e.g., elongation values, tensile strength values, AQL levels, powder weight) or qualitative (e.g., "non-irritating," "no sensitization potential") determined by standardized procedures.
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 is a medical device (exam glove) submission, not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (exam glove) submission, not an AI/algorithmic device.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on:
- Established Industry Standards: ASTM D 3578 (for latex exam gloves), ASTM D 6124 (for residual powder), ANSI, AAMI, ISO 11607 Parts 1 & 2 (for packaging integrity). These standards define the acceptable range or threshold for various performance metrics.
- Regulatory Requirements: 21 CFR Section 800.20 (for AQL/barrier defects) and general biological safety principles underlying primary skin irritation and sensitization tests.
- Internal Specifications: Cardinal Health's internal AQL of 1.5, which is a stricter requirement than the regulatory and ASTM standards.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (exam glove) submission, not an AI/learning algorithm. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for this type of device, this question is not relevant.
§ 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.