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510(k) Data Aggregation
(51 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.
Latex Examination Gloves - Powder Free
This document is a 510(k) summary for "Latex Examination Gloves - Powder Free" manufactured by PT. Tata Rubberindo Industries. It details the device's characteristics and its conformance to established standards.
Here's an analysis of the provided text to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Latex Examination Gloves - Powder Free" are primarily based on ASTM D 3578-95 Standard specifications for patient examination gloves and FDA pinhole requirements.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Dimensions: | |
| Length (XS, S, M, L, XL) | 240 mm (for all sizes) |
| Width (XS) | 111 mm |
| Thickness: | |
| Cuff (min) | 0.10 mm |
| Palm (min) | 0.10 mm |
| Finger Tip (min) | 0.10 mm |
| Physical Properties: | |
| Tensile Strength (Before aging) | ≥ 21 MPa |
| Tensile Strength (After aging at 70°C 168 hrs) | ≥ 16 MPa |
| Ultimate Elongation (Before aging) | ≥ 700 % |
| Ultimate Elongation (After aging at 70°C 168 hrs) | ≥ 600 % |
| Pinhole Requirement | Meets FDA pinhole requirement |
| Labeling Claims | Meets labeling claims |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size used for testing the device's performance against the ASTM D 3578-95 standard or the FDA pinhole requirement. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that PT. Tata Rubberindo Industries is based in Indonesia, it can be inferred that testing was conducted either internally, by contract labs, or by a combination of both, potentially in Indonesia or another country specified by the standard. The testing for the 510(k) submission would typically be prospective, as it's for pre-market clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device (patient examination gloves). The "ground truth" for the performance of gloves is established through objective physical and chemical testing against recognized consensus standards (like ASTM D 3578-95) rather than expert consensus on subjective observations. No medical experts or radiologists are involved in establishing the "ground truth" for these physical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where subjective interpretations or ambiguous cases require resolution by multiple experts. For physical and chemical testing of gloves, objective measurements are taken, and results are compared directly to the specified thresholds in the standard.
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
This information is not applicable. MRMC studies are used for evaluating the effectiveness of diagnostic devices, especially those involving human interpretation (e.g., radiology AI). This device is a physical barrier (glove), not a diagnostic tool, and does not involve human "readers" or AI assistance in its function.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. A "standalone" performance study refers to the evaluation of an algorithm's performance without human interaction, typical for AI/software as a medical device. This device is a physical product and does not involve any algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on objective measurements and laboratory testing conforming to:
- ASTM D 3578-95 Standard Specification for Rubber Examination Gloves: This standard defines the acceptable ranges for physical dimensions (length, width, thickness) and physical properties (tensile strength, ultimate elongation before and after aging).
- FDA Pinhole Requirement: This refers to the leak resistance of the gloves, ensuring they provide an effective barrier.
8. The sample size for the training set
This information is not applicable. This device is a manufactured product, not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this type of device. The "ground truth" (i.e., the performance requirements) refers to the established industry and regulatory standards mentioned in point 7.
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