(45 days)
Powdered 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 the healthcare personnel and the patient.
Powdered 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 powdered.
The device being discussed is "POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES".
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The device is marketed as substantially equivalent to a Class I Patient Examination glove (product code 80LYY) and is required to meet the specifications of ASTM D 3578-05, Standard Specification for Rubber Examination Gloves, and 21 CFR 800.20.
| Acceptance Criteria (Standard / Regulation) | Reported Device Performance |
|---|---|
| ASTM D 3578-05 (Standard Specification for Rubber Examination Gloves) | Gloves meet "all the current specifications listed under the ASTM Specification D 3578-05". |
| 21 CFR 800.20 | Testing performed per 21 CFR 800.20, implying compliance. |
| Biocompatibility (Primary skin irritation) | "Primary skin irritation testing in the rabbit... indicate no irritation." |
| Biocompatibility (Delayed dermal contact sensitization) | "...delayed dermal contact sensitization study in the guinea pigs indicate no... sensitization." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the specific performance tests (e.g., tensile strength, elongation, barrier integrity as per ASTM D 3578-05). However, such standards typically specify sampling plans. For the biocompatibility tests:
- Primary skin irritation: Not specified, but generally a small number of rabbits are used (e.g., 3-6).
- Delayed dermal contact sensitization: Not specified, but generally a small number of guinea pigs are used (e.g., 10-20).
- Data Provenance (Country of Origin): The studies were likely conducted in Malaysia, as the submitter's address is Malaysia.
- Retrospective or Prospective: The non-clinical tests described were prospective studies specifically conducted for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable for a device like examination gloves. The "ground truth" for glove performance is established by objective measurements against engineering standards (ASTM D 3578-05) and biological response in animal models, not by expert interpretation.
4. Adjudication Method for the Test Set
This is not applicable as the "test set" involves objective measurements and animal studies, not human interpretation requiring adjudication.
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 is not applicable. This device is an examination glove, not an AI-powered diagnostic or assistive technology for human readers. Therefore, no MRMC comparative effectiveness study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This device is an examination glove, not an algorithm or software. No standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
- For performance characteristics (e.g., strength, dimensions, barrier integrity): The ground truth is defined by the objective measurement specifications and tolerances outlined in ASTM D 3578-05. For example, a glove "passes" if its tensile strength exceeds a specific value.
- For biocompatibility: The ground truth for irritation and sensitization is based on the observed biological reactions in the animal models according to established toxicological testing protocols. "No irritation or sensitization" is the ground truth observed against the control group or baseline.
8. The Sample Size for the Training Set
This is not applicable. Examination gloves are manufactured using established processes; there is no "training set" in the context of machine learning or AI involved in their development or validation. The manufacturing process itself is continually optimized, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this device in the context of the provided information.
§ 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.