(96 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 Vinyl Patient Examination Gloves are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.
Here's a breakdown of the acceptance criteria and the study information for the "Powder Free Vinyl Patient Examination Gloves," based on the provided document:
This document is a 510(k) premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device. The information provided focuses on demonstrating that the new device performs at least as well as the predicate device and meets established standards. It does not describe an AI/ML device, so certain categories related to AI performance, such as multi-reader multi-case studies, effect size, and stand-alone algorithm performance, are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on established ASTM standards and FDA requirements for patient examination gloves. The reported device performance is indicated as "Meets" for all tested characteristics, signifying compliance with these standards.
| Characteristics | Standard / Acceptance Criteria | Device Performance (Subject Device) | Result of Comparison (to Predicate) |
|---|---|---|---|
| Product Code | LYZ (Predicate device code) | LYZ | Substantial equivalence |
| Intended Use | Predicate device's intended use | Predicate device's intended use | Substantial equivalence |
| Labeling | No special labeling claims / no hypoallergenic claim | No special labeling claims / no hypoallergenic claim | Substantial equivalence |
| Device Materials | Vinyl (Predicate device material) | Vinyl | Substantial equivalence |
| Color | Clear (Predicate device color) | Clear | Substantial equivalence |
| Tensile strength (before and after aging) | ASTM D 5250-06 (Reapproved 2011) | Meets | Substantial equivalence |
| Ultimate elongation (before and after aging) | ASTM D 5250-06 (Reapproved 2011) | Meets | Substantial equivalence |
| Freedom from pinholes | ASTM D 5250-06 (Reapproved 2011) & 21CFR800.20 | Meets | Substantial equivalence |
| Dimensions: Overall length, Width, Palm and Finger thickness | ASTM D 5250-06 (Reapproved 2011) | Meets | Substantial equivalence |
| Residual powder | ASTM D 5250-06 (Reapproved 2011) & ASTM D6124-06 (Reapproved 2011) | Meets | Substantial equivalence |
| Primary skin irritation test | ISO 10993-10 | Not an irritant | Substantial equivalence |
| Dermal sensitization assay | ISO 10993-10 | Not a sensitizer | Substantial equivalence |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (e.g., tensile strength, pinholes, biocompatibility). However, it implies that the tests were conducted according to the methodology outlined in the cited ASTM and ISO standards, which would specify appropriate sample sizes.
- Data Provenance: The tests were conducted by the manufacturer, Ever Light Plastic Products Co., Ltd., based in Donggao Industrial Zone, Zanhuang, Shijiazhuang, Hebei, China. The data would therefore be prospective data generated from their product testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of device submission. The "ground truth" for the performance of these examination gloves is established by objective measurements and standardized test methods (e.g., ASTM, ISO standards) rather than expert consensus on diagnostic interpretations. The tests are physical and chemical property assessments.
4. Adjudication method for the test set
Not applicable. As the tests involve objective physical and chemical property measurements against established standards, there is no need for an adjudication method by experts. The results are quantitative and directly assess compliance with the standard's specifications.
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
This is not applicable as the device is a vinyl patient examination glove, not an AI/ML device requiring human reader interaction or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a vinyl patient examination glove, not an AI/ML algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on objective, standardized measurements against internationally recognized specifications and test methods. Specifically:
- ASTM D 5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application: This standard defines the acceptable ranges and methods for testing physical properties like tensile strength, elongation, dimensions, freedom from pinholes, and residual powder.
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization: This standard defines the methodology for biocompatibility testing related to skin irritation and sensitization.
- 21 CFR 800.20: This FDA regulation pertains to specific requirements for medical devices, which includes aspects like freedom from holes.
- 21 CFR 807.92: This specifies requirements for the 510(k) summary.
8. The sample size for the training set
This is not applicable as the device is not an AI/ML model that requires a training set. The manufacturing process of examination gloves is based on engineering specifications and quality control, not machine learning.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of medical 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.