(186 days)
A glove is worn on the hand of healtcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment
Latex Patient Examination glove ( . color)
This document is a 510(k) summary for a latex patient examination glove. It outlines the specifications and quality characteristics of the glove, demonstrating its compliance with relevant standards.
Here's an analysis of the provided information in the requested format:
1. Table of acceptance criteria and the reported device performance
| Description | ASTM Standard (Acceptance Criteria) | Reported Device Performance (Specification) |
|---|---|---|
| DIMENSION | S-2 AQL 4.0 | S-2 AQL 4.0 |
| Overall length | 230 mm MIN. | 240 +/- 10 mm |
| Width (double wall) | S 80 +/- 10 mm | SS 77 +/- 5 mm |
| M 95 +/- 10 mm | S 83 +/- 5 mm | |
| L 111 +/- 10 mm | M 94 +/- 5 mm | |
| L 105 +/- 4 mm | ||
| Thickness, mm | ||
| Finger | 0.08 mm MIN. | 0.08 mm MIN. |
| Palm | 0.08 mm MIN. | 0.08 mm MIN. |
| PHYSICAL PROPERTIES | S-2 AQL 4.0 | S-2 AQL 4.0 |
| Before aging | ||
| Tensile strength | 14 Mpa MIN. | 14 Mpa MIN. |
| Elongation at break | 700 % MIN. | 700 % MIN. |
| After aging | ||
| Tensile strength | 14 Mpa MIN. | 14 Mpa MIN. |
| Elongation at break | 500 % MIN. | 500 % MIN. |
| POWDER LEVEL | N/A | S-2 AQL 4.0 |
| Inside | 2.5 +/- 1.0 % | |
| Outside | 1.0 % MAX. | |
| FREEDOM FROM HOLE | S-4 AQL 4.0 | II AQL 1.5 |
2. Sample size used for the test set and the data provenance
The document specifies the "S-2 AQL 4.0" and "S-4 AQL 4.0" for various tests (e.g., Dimension, Physical Properties, Freedom From Hole). AQL (Acceptable Quality Level) is a sampling standard, but it does not directly state the sample size used for the specific testing presented. It implies an inspection plan based on AQL, but the actual number of units tested is not explicitly provided.
The data provenance is from Thailand, as the applicant is Siam Sempermed Corporation.,Ltd, located in Thailand, and the Guinea pig Sensitization study was conducted at Prince of Songkla University, Department of Pharmacology, Faculty of Science, also in Thailand. The studies appear to be prospective as they are testing the product for its specifications directly stated in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For the technical performance of the glove (dimensions, physical properties, powder level, freedom from hole), the "ground truth" is established by adherence to the ASTM standard D3578-95 and the internal specifications shown. There is no mention of "experts" in the context of interpreting results for these objective measurements; rather, it's about meeting predefined numerical thresholds.
For the Guinea pig Sensitization (Buehler) test, the study was conducted by the "Prince of Songkla University, Department of Pharmacology Faculty of Science." While the specific number and qualifications of experts (e.g., toxicologists, veterinarians) involved in this study are not detailed, it can be inferred that appropriate scientific personnel from the pharmacology department conducted the experiment.
4. Adjudication method for the test set
There is no mention of an "adjudication method" in the context of interpretation by multiple experts for the performance criteria of the medical device (latex glove). The evaluation is based on objective measurements against pre-defined specifications and AQLs. For the Guinea pig sensitization test, the interpretation of results would have been by the scientific team conducting the study, but no specific adjudication method (like 2+1, 3+1 consensus) among multiple readers is described.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document pertains to a latex patient examination glove, which does not involve human readers interpreting medical images or data, nor does it involve AI assistance in its primary function.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (glove), not an algorithm or AI system.
7. The type of ground truth used
For the physical and dimensional properties of the glove, the ground truth is based on objective measurements against established engineering specifications and the ASTM standard D3578-95.
For the sensitization study, the "ground truth" for the non-sensitizing potential was established through an animal model experiment (Guinea pig Sensitization (Buehler) test), which is a recognized scientific method for assessing contact sensitization. The outcome is a direct observation of the animals' reaction (or lack thereof).
8. The sample size for the training set
Not applicable. This document describes a physical medical device (latex glove) and its testing, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As stated above, this is a physical medical device, not an AI/ML algorithm.
§ 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.