(127 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powdered Latex Examination Gloves. non-sterile.
The provided text describes a 510(k) premarket notification for "Powdered Latex Examination Gloves" by THAI HUA HOLDING CO. LTD. It outlines the device's characteristics, intended use, and conformance to standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578-05 | Meets |
| Physical Properties | ASTM D 3578-05 | Meets |
| Freedom from Holes | ASTM D 3578-05 | |
| ASTM D 5151-06 | Meets | |
| AQL 1.5 | ||
| Residual Powder | ASTM 6124-06 | Less than 10 mg per dm² |
| Protein Content | ASTM D 5712-99 | Less than 200 µg per dm² |
| Biocompatibility (Irritation) | Primary Skin Irritation in Rabbits | |
| CPSC Title 16, Chapter II, Part 1500:41 | Passes | |
| Biocompatibility (Sensitization) | Guinea Pig Sensitizations | |
| ISO 10993-10: 2002(E) | Passes |
The "DEVICE PERFORMANCE" column indicates that the gloves meet or pass the specified criteria, demonstrating compliance with the referenced ASTM, CPSC, and ISO standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set (e.g., how many gloves were tested for dimensions, holes, etc.).
It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). The testing appears to be conducted by the manufacturer to demonstrate compliance with international 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 and therefore not provided in the document. The "ground truth" for this type of device (examination gloves) is established by adherence to predefined objective physical and chemical standards (e.g., ASTM, ISO), not by expert opinion or interpretation in a medical imaging or diagnostic context.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., medical image reading) where disagreements between experts need to be resolved. For objective physical and chemical tests, the results are quantifiable and do not require adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the impact of an AI algorithm on their performance is being evaluated. For medical gloves, the performance is assessed against objective technical standards, not through human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective, verifiable physical and chemical standards as defined by:
- ASTM D 3578-05: Standard Specification for Rubber Examination Gloves (for dimensions, physical properties, freedom from holes).
- ASTM D 5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM 6124-06: Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D 5712-99: Standard Test Method for the Measurement of Latex Allergens in Natural Rubber and Latex Products.
- CPSC Title 16, Chapter II, Part 1500:41: For Primary Skin Irritation in Rabbits.
- ISO 10993-10: 2002(E): Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (specifically for Guinea Pig Sensitizations).
These standards provide the definitive criteria against which the device's performance is measured.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI/ML model that requires a training set. The manufacturing process of gloves does not involve machine learning training sets.
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 physical 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.