(248 days)
Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves 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 Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
The provided text details the 510(k) summary for the "Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves" (K141224), demonstrating its substantial equivalence to a predicate device. The information below is extracted and organized to address your request, focusing on acceptance criteria and the study proving compliance.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM D5250-06 (Reaffirmation 2011) standard, ASTM D5151-06 (Reapproved 2011), ASTM D6124-06 (Reaffirmation 2011), and ISO 10993-10 Third Edition 2010-08-01 for biocompatibility.
| Acceptance Criteria (Standard & Characteristic) | Device Performance (Subject Device K141224) | Result |
|---|---|---|
| ASTM D5250-06 (Reaffirmation 2011) | ||
| - Length | ≥230mm min. for all sizes | Meets |
| - Width (Small) | 83-87 mm | Meets |
| - Width (Medium) | 94-97 mm | Meets |
| - Width (Large) | 103-107mm | Meets |
| - Width (X Large) | 113-116 mm | Meets |
| - Thickness (Finger) | 0.05mm min. | Meets |
| - Thickness (Palm) | 0.08mm min. | Meets |
| - Physical Properties (Before aging): | Elongation ≥300%, Tensile Strength ≥14MPa | Meets |
| - Physical Properties (After aging): | Elongation ≥300%, Tensile Strength ≥14MPa | Meets |
| ASTM D5151-06 (Reapproved 2011) | ||
| - Freedom from Pinholes | Inspection Level I, AQL 2.5 (Meets 21 CFR 800.20) | Meets |
| ASTM D6124-06 (Reaffirmation 2011) | ||
| - Residual Powder | Generated values below 2mg of residual powder | Meets |
| ISO 10993-10 Third Edition 2010-08-01 | ||
| - Biocompatibility (Skin Irritation) | Not an irritant under the conditions of the study | Meets |
| - Biocompatibility (Sensitization) | Not a sensitizer under the conditions of the study | Meets |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for the individual tests (e.g., pinhole, tensile strength, residual powder). It only states that the device "meets" the requirements of the standards. The data provenance is implied to be from the manufacturer, Shijiazhuang Jiuyuan Plastic Co., Ltd. for the subject device, and Hebei Leader Plastic Co., Ltd. for the predicate device. The nature of the studies (retrospective or prospective) is not explicitly mentioned but typically for these types of device clearances, the performance data would be generated prospectively during product development and testing. The country of origin of the data is China, as both the submitter and predicate device manufacturer are based in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a patient examination glove, and the "ground truth" for its performance is established by standardized physical and chemical tests, not by expert interpretation of patient data or images. The tests are designed to objectively measure properties like tensile strength, pinholes, and biocompatibility.
4. Adjudication method for the test set
Not applicable. The "ground truth" for this device is based on objective measurements and compliance with established ASTM and ISO standards, not on subjective assessments requiring 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 product (patient examination glove), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical product, not an algorithm.
7. The type of ground truth used
The ground truth used for this device's acceptance is based on:
- Industry Standards: Compliance with specific physical and chemical property limits defined by ASTM International standards (D5250-06, D5151-06, D6124-06).
- Biocompatibility Standards: Compliance with limits defined by ISO (10993-10).
- Regulatory Requirements: Compliance with regulations like 21 CFR 800.20 for freedom from pinholes.
These standards serve as the objective "ground truth" against which the device's performance is measured.
8. The sample size for the training set
Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a physical product, there is no ground truth established for one.
§ 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.