(24 days)
A 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.
POWDERED VINYL EXAM GLOVES, WHITE, Class I Device, 80LYZ. A 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.
The provided text describes the regulatory clearance for "POWDERED VINYL EXAM GLOVES, WHITE" (K030927) and references its substantial equivalence to another device (K021961). The acceptance criteria for medical gloves are typically defined by recognized standards such as ASTM. The document states that the device met or exceeded specific ASTM standards and other tests.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards/Tests) | Reported Device Performance |
|---|---|
| ASTM D 5250-00E4 | Met or exceeded |
| ASTM D 5151-99 | Met or exceeded |
| ASTM D 6124-01 | Met or exceeded |
| ISO 2859 | Met or exceeded |
| MIL Std 105E | Met or exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded |
| Bio-Compatibility: Primary Skin Irritation | Met or exceeded |
| Bio-Burden (Procedure Method 8315) | Met or exceeded |
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 explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). This information is typically detailed in the full test reports, which are not included here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. Testing for medical gloves (physical properties, biocompatibility) typically involves laboratory testing against established standards, not necessarily relying on expert "ground truth" panels in the same way an AI diagnostic tool might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of device and testing described. The performance is assessed against standardized objective measurements defined by ASTM, ISO, and MIL standards, 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
No such study was conducted or mentioned. This type of study is relevant for AI-powered diagnostic tools where human interpretation is assisted by AI, which is not the case for examination gloves.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable for an examination glove. There is no algorithm or AI component in this device. The device itself (the glove) is the standalone entity being evaluated for its physical and biocompatibility properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for examination gloves is defined by the objective, measurable performance requirements specified in the referenced ASTM, ISO, and MIL standards for physical properties (e.g., tensile strength, elongation, barrier integrity) and validated laboratory tests for biocompatibility (dermal sensitization, primary skin irritation, bioburden).
8. The sample size for the training set
This is not applicable as this device is an examination glove and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.