(61 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00E4.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Disposable Powder Free Vinyl Exam Glove, Yellow Color:
This document is a 510(k) summary for a medical device (a disposable glove), not a typical AI/ML medical device submission. Therefore, many of the requested categories (like MRMC study, ground truth for training set, number of experts for ground truth, etc.) are not applicable as they relate to advanced diagnostic or AI-driven devices. The focus here is on demonstrating substantial equivalency to a predicate device through established physical performance and biocompatibility standards.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM D5250-00E4 (Overall Standard) | Conforms fully |
| Dimensions Testing (AQL 4.0, S-2) | Meets requirements¹ |
| FDA 1000 ml Watertight Test | Meets requirements¹ |
| (ASTM D-5151-99, AQL 2.5, Insp. Level I) | |
| Primary Skin Irritation/Sensitization | No primary skin irritant or sensitization reactions |
| Residual Powder Test (ASTM D6124-01) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
| Biocompatibility | Meets requirements¹ |
| Pinhole FDA requirements | Meets requirements¹ |
¹ The document states the device "meets these requirements" or "conforms fully" or "meets requirements" without providing specific measured values for dimensions, watertight test, biocompatibility, or pinhole requirements in the summary. It refers to data in Section 7 which is not fully elaborated with raw numbers.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Dimensions Testing: Inspection level S-2, AQL 4.0. (Specific sample size 'n' is not explicitly stated, but derived from AQL and inspection levels).
- FDA 1000 ml Watertight Test: AQL 2.5, Inspection level I. (Specific sample size 'n' is not explicitly stated, but derived from AQL and inspection levels).
- Primary Skin Sensitization Test: Not specified.
- Residual Powder Test: Not specified.
- Data Provenance: The manufacturing company is Ever Global Enterprise Corporation, based in Dong Nai Province, Vietnam. The tests were likely conducted on gloves produced at this facility. The document doesn't explicitly state if the testing was prospective (done specifically for this submission) or retrospective (using existing factory QA data), but it's implied to be part of the product's quality assurance and validation for this submission.
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)
Not applicable. This device is a physical product (a glove), not a diagnostic device requiring expert interpretation for ground truth. Performance is measured against established physical and chemical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication method.
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 device is not an AI-driven or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an 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 adherence to established national and international standards for medical examination gloves, specifically:
- ASTM D5250-00E4 (Standard specification for Vinyl Examination Gloves for Medical Application)
- ASTM D-5151-99 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-01 (Standard Test Method for Residual Powder on Medical Gloves)
- FDA's 1000 ml Watertight Test (which cites ASTM D-5151-99)
- Biocompatibility requirements (Primary Skin Sensitization)
These standards define objective measurement criteria rather than requiring subjective human "ground truth" interpretation.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML model that requires a training set.
§ 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.