(99 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 380,6250. Powder free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00 E4
The provided text describes a 510(k) summary for a "Powder free Vinyl Examination Glove" and focuses on establishing its substantial equivalence to a predicate device, rather than presenting a study demonstrating acceptance criteria met by the device itself in a typical AI/software context.
Therefore, many of the requested fields are not applicable to this type of submission. However, I will extract the available information and indicate where specifics about a performance study are missing.
Analysis of the Document for AI/Software Device Acceptance Criteria and Study:
The document describes a medical device, specifically a "Powder free Vinyl Examination Glove." This is a physical, disposable medical device, not an AI or software device. As such, the concept of "acceptance criteria" and "study" in the context of AI performance (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies, training/test sets) does not directly apply.
Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device (Shanghai Foremost Vinyl Patient Examination Glove, Powder free, 510(k) #K971415). This is a regulatory pathway for Class I and Class II devices in the US, where the new device is shown to be as safe and effective as a legally marketed device.
Table of Acceptance Criteria and Reported Device Performance (as translated for a physical device and substantial equivalence):
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Indications for use: Identical to predicate | Identical |
| Target population: Identical to predicate | Identical |
| Design: Similar to predicate | Similar |
| Materials: Similar to predicate | Similar |
| Performance: Identical to predicate (meets ASTM Standard D5250-00 E4) | Identical (meets ASTM Standard D5250-00 E4) |
| Sterility: Identical to predicate | Identical |
| Biocompatibility: Identical to predicate | Identical |
| Mechanical safety: Identical to predicate | Identical |
| Chemical safety: Identical to predicate | Identical |
| Anatomical sites: Identical to predicate | Identical |
| Human factors: Identical to predicate | Identical |
| Energy used and/or delivered: Not applicable to predicate | Identical (Not applicable) |
| Compatibility with environment and other devices: Identical to predicate | Identical |
| Where used: Identical to predicate | Identical |
| Standards met: Identical to predicate | Identical |
| Electrical safety: Not applicable to predicate | Identical (not applicable) |
| Thermal safety: Not applicable to predicate | Identical (not applicable) |
| Radiation safety: Not applicable to predicate | Identical (not applicable) |
Missing Information (Not applicable to this type of device/submission):
The following information is primarily relevant for AI/software-based medical devices and is therefore not found in this 510(k) submission for a physical glove:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical glove. Performance is typically assessed through physical testing (e.g., tensile strength, puncture resistance, barrier integrity) against established standards (like ASTM D5250-00 E4) rather than data from a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a glove involves objective measurements and compliance with material standards, not expert interpretation of data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical glove, the "ground truth" would be objective measurements against an engineering standard (e.g., ASTM D5250-00 E4), not expert consensus or pathology.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a 510(k) summary for a physical medical device (examination glove) seeking substantial equivalence to a predicate device. It demonstrates performance by claiming adherence to an ASTM standard and direct comparison of characteristics to a previously cleared device, not through an AI-style performance study with test sets, ground truths, or expert evaluations.
§ 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.