(140 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
This document is a 510(k) Summary for medical gloves (Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored)). It does not describe an AI/ML device but rather a physical medical device. Therefore, much of the requested information regarding AI/ML device evaluation is not applicable.
However, I can extract information related to the acceptance criteria and the "study" (which in this case refers to non-clinical testing against standards) that proves the device meets these criteria, as presented in the document for this specific medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature & Description | Acceptance Criteria (from ASTM Standard) | Reported Device Performance | Assessment |
|---|---|---|---|
| Dimensions - Length | >230mm min. (ASTM D5250-06 (Reapproved 2011)) | 230mm min for all sizes (Meets ASTM D5250-06 (Reapproved 2011)) | Substantially equivalent |
| Dimensions - Width | Small 80-90 mm | ||
| Medium 90-100mm | |||
| Large 100-110mm | |||
| X large 110-120 mm (ASTM D5250-06 (Reapproved 2011)) | Small 84-86 mm | ||
| Medium 94-96 mm | |||
| Large 104-106mm | |||
| X large 113-115 mm (Meets ASTM D5250-06 (Reapproved 2011)) | Substantially equivalent | ||
| Dimensions - Thickness | Finger 0.05mm min. | ||
| Palm 0.08mm min. (ASTM D5250-06 (Reapproved 2011)) | Finger 0.05mm min. | ||
| Palm 0.08mm min. (Meets ASTM D5250-06 (Reapproved 2011)) | Substantially equivalent | ||
| Physical Properties (Before aging/after aging) | Elongation ≥300% | ||
| Tensile Strength ≥ 11MPa (ASTM D5250-06 (Reapproved 2011)) | Elongation ≥300% | ||
| Tensile Strength ≥ 11MPa (Meets ASTM D5250-06 (Reapproved 2011)) | Substantially equivalent | ||
| Freedom from Pinholes | Meets 21 CFR 800.20 | ||
| ASTM D5250-06 (Reapproved 2011) | |||
| ASTM D 5151-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011) | ||
| Holes Inspection Level I | |||
| AQL 2.5 | Substantially equivalent | ||
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) | ASTM D6124-06 (Reaffirmation 2011) | |
| Results generated values below 2mg of residual powder | Substantially equivalent | ||
| Biocompatibility | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10:2002/Amd.1:2006 | Under the conditions of the study, the device is not a sensitizer or an irritant. | |
| SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 Third Edition 2010-08-01 | Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for testing each individual criterion (e.g., number of gloves tested for pinholes, tensile strength, etc.). It refers to meeting the requirements of specific ASTM standards. These standards typically define sampling plans that manufacturers must follow.
The provenance of the data is from the manufacturer's own testing in China, as the submitter is Zibo Yusheng Plastic Products Company Limited based in China. The testing would be considered prospective for the purpose of demonstrating conformance to standards for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The "ground truth" for a physical medical device like a patient examination glove is established by adherence to recognized voluntary consensus standards (like ASTM standards) and FDA regulations. It does not involve expert consensus in the same way an AI/ML diagnostic device would. Performance is measured objectively against specified physical and chemical requirements.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation involves objective measurement against predefined standard specifications rather than interpretive or subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This is not applicable for a physical medical device like an examination glove. MRMC studies are relevant for diagnostic AI/ML systems where human interpretation plays a role.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as the device is not an algorithm or AI/ML system.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is defined by:
- Voluntary Consensus Standards: Specifically, ASTM D5250-06 (Reaffirmation 2011) for vinyl patient examination gloves, ASTM D5151-06 (Reapproved 2011) for detection of holes, and ASTM D6124-06 (Reaffirmation 2011) for residual powder.
- FDA Regulations: 21 CFR 800.20 (for freedom from pinholes).
- International Standards for Biocompatibility: ISO 10993-10 Third Edition 2010-08-01 for skin irritation and sensitization.
These standards and regulations establish the objective criteria (e.g., minimum tensile strength, maximum allowable pinholes) that the device must meet.
8. The Sample Size for the Training Set
This information is not applicable. There is no concept of a "training set" for physical medical devices like these gloves in the context of an AI/ML model. Manufacturers conduct process validation and quality control measures during manufacturing, but these are distinct from AI/ML training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no "training set" in the AI/ML sense for this device. The manufacturer's internal quality systems and adherence to good manufacturing practices ensure consistent product quality, relying on the established performance standards mentioned above.
§ 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.