(10 days)
This is a medical glove worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I Latex Patient Examination Glove 80 LYY, powder free that meets all of the requirements of ASTM Standard D3578-95 and FDA Water leak test.
The provided text describes the acceptance criteria and performance data for Evergreen Non-Sterile Powder Free Latex Examination Gloves.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D3578-95 & FDA) | Reported Device Performance (EVERGREEN POWDER FREE LATEX EXAMINATION GLOVE) |
|---|---|---|
| Watertight (1000ml) | G II AQL = 4.0% | Pass G II AQL = 4.0 % |
| Length (mm) | ||
| Size XS, S, M, L | Min 230 | 240 mm minimum for all sizes |
| Size XL | - | (Not specified, but covered by "all sizes") |
| Palm Width (mm) | ||
| Size XS | - | 73 - 78 |
| Size S | 80 +/- 10 | 83 - 88 |
| Size M | 95 +/- 10 | 93 - 98 |
| Size L | 111 +/- 10 | 103 - 107 |
| Size XL | - | (Not specified, but presumably within ranges if offered) |
| Thickness (mm) (Single Layer) | ||
| Finger | min 0.08 | 0.10 minimum |
| Palm | min 0.08 | 0.10 minimum |
| Physical Properties - Before Ageing | ||
| Tensile Strength (Mpa) | min 14 | 26.5 |
| Ultimate Elongation (%) | min 700 | 810 |
| Physical Properties - After Ageing | ||
| Tensile Strength (Mpa) | min 14 | 22.3 |
| Ultimate Elongation (%) | min 500 | 750 |
| Powder Content | (FDA Requirements) | below 2 mg / glove |
| Protein Content | - | below 50 microgram / gram |
| Biocompatibility Tests (Primary Dermal Irritation, Guinea Pig Sensitization) | (Pass) | Pass |
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., number of gloves tested for watertightness, length, etc.). It refers to "Performance data of gloves based on ASTM D3578-95 and FDA 1000 ml watertight test." and the results presented in the summary tables.
The data provenance is retrospective in the context of the 510(k) submission, as the tests have already been performed and the results are being presented.
The country of origin for the data is implied to be Malaysia, as the submitter, YTY Industry (Manjung) Sdn Bhd, is located in Malaysia.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the document describes performance testing for medical gloves against established standards (ASTM D3578-95 and FDA requirements), not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is defined by the objective measurements performed according to these standards.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are objective measurements against predefined standards, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. The described device is a medical glove, for which such a study is not appropriate.
6. Standalone Performance Study (Algorithm Only)
A standalone performance study was not done (or is not applicable). The device itself is a physical product (a glove), not an algorithm. The performance data presented in the table are the standalone performance of the glove itself against physical and chemical specifications.
7. Type of Ground Truth Used
The ground truth used is based on objective measurements and adherence to established industry standards and regulatory requirements. Specifically:
- ASTM D3578-95 Standard: This standard provides specifications for latex examination gloves, defining acceptable ranges for properties like watertightness, dimensions, and physical properties (tensile strength, elongation).
- FDA Pinhole Requirements (1000ml watertight test): A specific regulatory requirement for glove integrity.
- FDA Minimum Powder Residual Content: A regulatory requirement for the amount of powder on the glove.
- Biocompatibility Tests: Standards-based tests to assess the biological safety of the material.
8. Sample Size for the Training Set
This information is not applicable. The described device is a physical product (a glove) and does not involve AI or machine learning algorithms that would require a "training set." The manufacturing process of gloves does not involve a "training set" in the context of AI development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated 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.