(202 days)
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Polyethylene Examination Gloves are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of translucent (clear) Low Density Polyethylene materials and are powder free. The gloves are loose fitting. The physical and performance characteristics of the devices meet all requirements of ASTM standard D-5250-06 (2011) Standard Specification for Poly(vinyl Chloride) Gloves for Medical Application.
The provided text is a 510(k) summary for "Powder Free Polyethylene Examination Gloves," which is a Class I medical device. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials. Therefore, the acceptance criteria and study information typically found for AI/ML-driven medical devices or complex diagnostic devices are not present.
Based on the document, here's an analysis of the provided information, noting where specific details (like those related to AI/ML studies) are not applicable:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are based on meeting established ASTM standards for patient examination gloves and demonstrating biocompatibility. The "reported device performance" section directly states that the subject device "Meets" these standards, indicating compliance. The table combines acceptance criteria with reported performance, as the predicate device also "Meets" these, establishing substantial equivalence.
| Characteristics | Standard | Predicate Device Performance | Subject Device Performance | Comparison |
|---|---|---|---|---|
| Product Code | / | LZA | LZA | Substantial equivalence |
| Intended Use | / | Meets | Meets | Substantial equivalence |
| Labeling | / | Meets | Meets | Substantial equivalence |
| Device Materials | / | Polyethylene | Polyethylene | Substantial equivalence |
| Color | / | Translucent (Clear) | Translucent (Clear) | Substantial equivalence |
| Tensile strength: before and after aging | ASTM D5250-06 (2011) | Meets | Meets | Substantial equivalence |
| Ultimate elongation: before and after aging | ASTM D5250-06 (2011) | Meets | Meets | Substantial equivalence |
| Freedom from pinholes | ASTM D5250-06 (2011) | Meets | Meets | Substantial equivalence |
| Dimensions: Overall length, Width, Palm and Finger thickness | ASTM D5250-06 (2011) | Meets | Meets | Substantial equivalence |
| Residual powder | ASTM D5250-06 (2011), ASTM D6124-06 | Meets | Meets | Substantial equivalence |
| Primary skin irritation test | ISO 10993 Part 10 | Passes | Passes | Substantial equivalence |
| Dermal sensitization assay | ISO 10993 Part 10 | Passes | Passes | Substantial equivalence |
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 specify a "test set" sample size in the context of clinical trials or AI/ML model validation, because this submission is for a Class I general purpose glove based on performance standards. The testing performed (such as dimensions, physical properties, freedom from holes, residual powder, and biocompatibility) would have involved specific sample sizes as determined by the relevant ASTM and ISO standards, but these details are not provided in the summary beyond stating "Meets" or "Passes."
Data provenance would typically refer to the source of patient data. Since this is non-clinical testing of a physical device, there is no patient data involved. The tests were performed on the manufactured gloves.
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. "Ground truth" in the context of expert consensus is typically relevant for diagnostic devices interpreting medical images or other complex data. For examination gloves, the "ground truth" is defined by the objective physical and chemical testing standards (ASTM, ISO). The results are determined by laboratory measurements, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used to resolve discrepancies among experts in interpreting complex data (e.g., medical images). As the ground truth is established by objective physical and chemical tests, there is no need for expert 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 device is a physical examination glove and does not involve AI, human readers, or the interpretation of medical cases. MRMC studies and effect sizes related to AI assistance are irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product and does not involve algorithms or AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective engineering and biocompatibility standards. Specifically:
- ASTM D 5250-06 (2011) for physical properties (dimensions, tensile strength, elongation, freedom from holes) and residual powder.
- ASTM D6124-06 (Reapproved 2011) for residual powder.
- ISO 10993 Part 10 for primary skin irritation and dermal sensitization (biocompatibility).
- FDA 21 CFR 800.20 for freedom from holes.
These standards provide measurable criteria that determine whether the device meets its intended specifications.
8. The sample size for the training set
Not applicable. There is no AI/ML model, and therefore no training set. The "training" for this product involves adhering to manufacturing processes that enable the gloves to meet the predefined standards.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML training set, there is no ground truth establishment for it.
§ 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.