(66 days)
Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-05, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powder free.
The provided document is a 510(k) summary for "NON-CHLORINATED, POLYMER COATED, POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES." This pertains to a medical device (examination gloves) and not a software algorithm. Therefore, many of the questions asked about acceptance criteria and study design for software performance are not directly applicable.
However, I can extract the information that is relevant to the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" for this physical device.
Here's the breakdown based on the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Specification) | Reported Device Performance |
|---|---|
| ASTM D 3578-05, Standard Specification for Rubber Examination Gloves | "Gloves meet all the current ASTM D 3578-05 requirements." |
| 21 CFR 800.20 (Biocompatibility) | "Primary skin irritation testing... indicate no irritation or sensitization." |
| Presence of Starch | "Final product has been tested negative for the presence of starch using the USP iodine test." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the non-clinical tests. The tests were performed by MEDTEXX MANUFACTURING SDN. BHD. in Malaysia. These were non-clinical (laboratory and animal-based) tests, presumably prospective as they were conducted to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is evaluated against engineering standards (ASTM D 3578-05) and regulatory guidelines (21 CFR 800.20) for material properties and biocompatibility. There is no concept of "expert ground truth" in the diagnostic sense for this type of device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving interpretation of medical images or data by multiple experts. For physical device testing against standards, the results are typically objectively measured and compared to predefined thresholds.
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 question is not applicable. MRMC studies and the concept of AI assistance are related to diagnostic software or tools that aid human interpretation. This document describes a physical medical device (examination gloves), not a diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical product, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is defined by:
- ASTM D 3578-05 Standard: This standard specifies physical properties such as tensile strength, elongation, and dimensions for rubber examination gloves.
- 21 CFR 800.20: This regulation outlines biocompatibility requirements, which are assessed through tests like primary skin irritation and delayed contact sensitization.
- USP iodine test: Used to determine the absence of starch.
These are objective, measurable standards, not observational or interpretive ground truth established by experts in a clinical context.
8. The sample size for the training set
This question is not applicable. The concept of a "training set" applies to machine learning algorithms. This document describes the testing of a physical product against established engineering and biocompatibility standards.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above. There is no training set for this type of 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.