(52 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between and patient examiners that require a sterile procedure.
A latex examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners that require a sterile procedure.
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This document is a 510(k) Summary for Latex Examination Gloves, Pre-powdered. It outlines the device's technical characteristics and performance data to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the provided information, structured to address your request about acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ASTM D 3578-95, a standard for Latex Examination Gloves. The reported device performance indicates compliance with these standards.
| Characteristic | Acceptance Criteria (ASTM D 3578-95) | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| Length (XS, S, M, L, XL) | ≥ 240 mm | 240 mm for all sizes (XS, S, M, L, XL) |
| Width (XS) | 111 mm | > 111 mm |
| Thickness (Cuff) | ≥ 0.10 mm | 0.10 mm (min) |
| Thickness (Palm) | ≥ 0.10 mm | 0.10 mm (min) |
| Thickness (Finger Tip) | ≥ 0.10 mm | 0.10 mm (min) |
| Physical Properties (Before Ageing) | ||
| Tensile Strength | 21 Mpa (min) | 21 Mpa (min) |
| Ultimate Elongation | 700 % (min) | 700 % (min) |
| Physical Properties (After Ageing at 100°C 22 hrs) | ||
| Tensile Strength | 16 Mpa (min) | 16 Mpa (min) |
| Ultimate Elongation | 600 % (min) | 600 % (min) |
| Performance Requirements (AQLs) | ||
| Visible Defects (Stains, Lumps, Holes etc.) | AQL 2.5 (Inspection Level S-4) | Meets AQL 2.5 |
| Watertight (Holes) | AQL 1.5 (Inspection Level S-4) | Meets AQL 1.5 (Meets FDA pinhole requirement) |
| Dimensions (Width, Length & Thickness) | AQL 4 (Inspection Level S-2) | Meets AQL 4 |
| Physical Properties (Before and after ageing) | AQL 4 (Inspection Level S-2) | Meets AQL 4 |
| Sterility (Fails sterility) | Not Acceptable | Meets the sterility assurance level |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample sizes for each test (e.g., number of gloves tested for dimensions, watertightness, etc.). However, it refers to "Inspection Level S-4" and "S-2" for various performance requirements, which are standard sampling plans defined in relevant quality control regulations (likely ISO 2859 or military standards for sampling by attributes). These levels imply specific sample sizes will be drawn based on the batch size, but the exact number isn't provided here.
Data Provenance: The manufacturing company is PT. Maja Agung Latexindo, located in Sumatera Utara, Indonesia. The tests were performed to meet the ASTM D 3578-95 standard, an international standard. The data itself is likely generated internally by the manufacturer during quality control processes. It is retrospective data, as it describes the performance of already manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of medical device (latex examination gloves) does not typically involve human experts to establish "ground truth" for performance tests in the same way an AI diagnostic algorithm might. The "ground truth" for these tests is defined by objective, measurable parameters (e.g., physical dimensions, tensile strength, absence of holes) as specified in the ASTM D 3578-95 standard. The tests are conducted using standardized methods and equipment. Therefore, there's no mention of experts establishing ground truth in terms of clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" for these tests is objective and quantitative, defined by the ASTM standard. There would be no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for comparing the diagnostic performance of human readers, often with and without AI assistance, especially in image interpretation. This document pertains to the physical and mechanical properties of medical gloves, not a diagnostic imaging device. Therefore, no MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "device" in this context is the physical latex glove. Its performance is evaluated directly through various laboratory tests (dimensional measurements, tensile strength tests, water leak tests, sterility tests) without human intervention in the interpretive phase (except for performing the tests and recording results). There is no "algorithm" involved in the performance testing of these gloves as there would be for an AI-powered device.
7. The Type of Ground Truth Used
The ground truth used is based on objective, quantitative measurements and adherence to established performance standards (ASTM D 3578-95). For example:
- Dimensions: Measured values compared against specified ranges.
- Physical Properties: Measured tensile strength and elongation compared against minimum requirements.
- Watertightness: Absence of holes determined by a water leak test, conforming to FDA pinhole requirements.
- Sterility: Absence of microbial growth, conforming to sterility assurance levels.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (latex gloves), not an artificial intelligence model or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.