(133 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).
The provided text describes a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)." This device is a Class I medical device, and the submission primarily focuses on demonstrating substantial equivalence to a predicate device by meeting established industry standards. Therefore, the concept of "acceptance criteria" and "study" in this context refers to compliance with these standards and the tests performed to verify this compliance, rather than a clinical study of AI performance.
Here's an analysis of the provided text in the requested format:
Acceptance Criteria and Device Performance Study
The acceptance criteria for the "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)" are primarily based on meeting the requirements of recognized ASTM standards (ASTM D5250-06 (Reaffirmation 2011), ASTM D5151-06 (Reaffirmed 2011), and ASTM D6124-06 (Reaffirmation 2011)) and biocompatibility testing (ISO 10993-10 Third Edition 2010-08-01). The study conducted involved non-clinical testing to demonstrate compliance with these standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions - Length | ASTM D5250-06 (Reapproved 2011) - ≥230mm min. | Meets ASTM D5250-06 (Reapproved 2011) - 230mm min. for all sizes |
| Dimensions - Width | ASTM D5250-06 (Reapproved 2011) - Small 80-90mm, Medium 90-100mm, Large 100-110mm, X large 110-120mm | Meets ASTM D5250-06 (Reapproved 2011) - Small 84-86mm, Medium 95-98mm, Large 104-107mm, X large 110-115mm |
| Dimensions - Thickness | ASTM D5250-06 (Reapproved 2011) - Finger 0.05mm min., Palm 0.08mm min. | Meets ASTM D5250-06 (Reapproved 2011) - Finger 0.05mm min., Palm 0.08mm min. |
| Physical Properties (Before/After aging) | ASTM D5250-06 (Reapproved 2011) - Elongation ≥300%, Tensile Strength ≥11MPa | Meets ASTM D5250-06 (Reapproved 2011) - Elongation ≥300%, Tensile Strength ≥11MPa |
| Freedom from Pinholes | ASTM D5151-06 (Reapproved 2011) - Inspection Level 1, AQL 2.5 | Meets ASTM D5151-06 (Reapproved 2011) - Holes Inspection Level 1, AQL 2.5 |
| Residual Powder | ASTM D6124-06 (Reaffirmation 2011) | Results generated values below 2mg of residual powder (Meets ASTM D6124-06) |
| Biocompatibility | ISO 10993-10 Third Edition 2010-08-01 (Skin Irritation, Sensitization) | The test article was a non-irritant or non-sensitizer (Meets ISO 10993-10) |
| Water Leak Test on Pinhole | FDA Requirements | Meets FDA requirements |
2. Sample Size for Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test within the ASTM standards. However, testing according to ASTM standards typically involves specified sample sizes for various measurements (e.g., for physical properties, pinholes). The data provenance is implied to be from non-clinical laboratory testing performed by the manufacturer (Jiawang Glove Co., Ltd.) to demonstrate compliance with the referenced standards. This type of data is retrospective in the sense that it's gathered specifically for the regulatory submission after product manufacturing and testing. The country of origin for the studies would be China, where the manufacturer is located.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. For this type of device (patient examination gloves), "ground truth" is established through standardized physical and chemical testing methods as defined by ASTM and ISO standards, rather than through expert consensus on interpretations of complex data like medical images. These tests are performed by trained technicians in a laboratory setting.
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements against defined numerical or qualitative thresholds in the standards rather than requiring expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-powered devices where human readers interpret medical cases. This device is a Class I physical barrier device, and its performance is evaluated against established physical and chemical standards.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is defined by the objective, quantitative, and qualitative limits specified in the referenced ASTM and ISO standards. For example, for "Freedom from Pinholes," the ground truth is "Inspection Level 1, AQL 2.5" as per ASTM D5151-06. For biocompatibility, the ground truth is "non-irritant or non-sensitizer" as determined by ISO 10993-10.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in that context. The "training" for such devices involves adherence to manufacturing processes and material specifications to consistently produce gloves that meet the stated standards.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of AI. The "ground truth" for the device's design and manufacturing (which could be metaphorically considered its "training") stems from adherence to the specified materials (PVC, PU coating) and manufacturing processes designed to meet the performance criteria outlined in the ASTM and ISO standards.
§ 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.