(39 days)
The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Powdered Examination Gloves (White)
The provided document describes an FDA 510(k) clearance for "Nitrile Powdered Examination Gloves (White)" (K050215). This is a manual device, not an AI or software-based device. Therefore, the questions regarding acceptance criteria and studies related to AI performance, such as sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable to this submission.
The clearance is based on substantial equivalence to legally marketed predicate devices, meaning the device performs as intended for its indicated use.
1. Table of Acceptance Criteria and Reported Device Performance:
For manual examination gloves, typical acceptance criteria relate to physical properties and barrier integrity to ensure they meet performance standards for their intended use (preventing contamination). These criteria are generally established by international standards (e.g., ASTM, EN standards). The FDA 510(k) summary (which is not fully provided here, only the clearance letter) would reference these standards and the device's compliance.
-
Acceptance Criteria (General for Examination Gloves):
- Freedom from holes: AQL (Acceptable Quality Level) of 2.5 or 4.0 for water leak test.
- Tensile Strength & Elongation: Must meet minimum requirements defined by standards (e.g., ASTM D412, EN 455-2).
- Dimensions (Length, Width, Thickness): Must be within specified ranges defined by standards.
- Powder Content (if powdered): Usually a maximum limit (e.g., 2 mg/glove).
- Biocompatibility: Must be non-toxic and non-irritating (e.g., ISO 10993 tests for cytotoxicity, sensitization, irritation).
-
Reported Device Performance:
The clearance letter states the device is "substantially equivalent" to legally marketed predicate devices for its indicated use: "a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This implies the device met the relevant performance standards for examination gloves, demonstrating its safety and effectiveness. Specific numerical performance data is not typically found in the FDA clearance letter itself but would be detailed in the 510(k) submission summary.
2. Sample size used for the test set and the data provenance:
- Not applicable for this type of device. Testing for examination gloves generally involves destructive and non-destructive testing on samples taken from production lots, following statistical sampling plans outlined in relevant standards (e.g., ISO 2859-1 for AQL sampling). This is not "data" in the context of clinical studies for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for this device is established by objective physical and chemical testing against defined standards, not by expert interpretation.
4. Adjudication method for the test set:
- Not applicable. Testing involves objective measurements, not subjective 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:
- Not applicable. This is a manual device, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a manual device, not an algorithm.
7. The type of ground truth used:
- For examination gloves, the "ground truth" is adherence to established international and national performance standards (e.g., ASTM D6319, EN 455 series) for physical properties (tensile strength, elongation, dimensions), barrier integrity (water leak test), and biocompatibility.
8. The sample size for the training set:
- Not applicable. This is a manual device, not an AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is a manual device, not an AI 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.