(145 days)
Powder free vinyl patient examination glove, colored (yellow) is a non-sterile, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder free vinyl patient examination glove, colored (yellow) are patient examination gloves available in S, M, L, XL. They are provided non-sterile and meet the entire requirement of ASTM standard D5250-06(reapproved), except for sterility requirements.
This document describes the 510(k) premarket notification for the "Powder free vinyl patient examination glove, colored (yellow)" (K160675). The submission aims to demonstrate substantial equivalence to a predicate device, the "White vinyl patient examination glove" (K143277) from Life safety products (Hui Zhou) Co., Ltd.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Subject Device, K160675) | Predicate Device Performance (K143277) | Comparison Comment |
|---|---|---|---|
| Dimensions | |||
| Length | $\geq$ 230mm | 243mm | Substantially Equivalent |
| Width (S Size) | 85±5mm | 85mm | Substantially Equivalent |
| Width (M Size) | 95±5mm | 95mm | Substantially Equivalent |
| Width (L Size) | 105±5mm | 105mm | Substantially Equivalent |
| Width (XL Size) | 115±5mm | 115mm | Substantially Equivalent |
| Finger thickness | $\geq$ 0.05mm | 0.05mm | Substantially Equivalent |
| Palm thickness | $\geq$ 0.08mm | 0.08mm | Substantially Equivalent |
| Overall dimension | Meets ASTM D5250-06 | Meets ASTM D5250-06 | Substantially Equivalent |
| Physical Properties | |||
| Tensile strength | $\geq$ 11MPa | 15.7MPa | Substantially Equivalent |
| Elongation | $\geq$ 300% | 385% | Substantially Equivalent |
| Overall physical properties | Meets ASTM D5250-06 | Meets ASTM D5250-06 | Substantially Equivalent |
| Freedom from Pinhole | Pinhole = 0/200; AQL 2.5; Meets ASTM D5151-06 | Pinhole = 10/500; AQL 1.5; Meets ASTM D5151-06 | Substantially Equivalent |
| Powder Residual | Powder residual = 0.5mg per glove; Meets ASTM D5250-06 and D6124-06 | Powder residual = 1mg; Meets ASTM D5250-06 and D6124-06 | Substantially Equivalent |
| Cytotoxicity | Per ISO10993-5, under the conditions tested, the subject glove is non-cytotoxic. | Per ISO10993-5, under the conditions tested, the subject glove is non-cytotoxic. | Substantially Equivalent |
| Biocompatibility | Per ISO10993-10, under the conditions tested, the subject glove was non-sensitizing and non-irritating. | Per ISO10993-10, under the conditions tested, the subject glove was non-sensitizing and non-irritating. | Substantially Equivalent |
Note: The "acceptance criteria" for the subject device are generally presented as meeting relevant ASTM and ISO standards, with specific values reported for the subject device's performance which are then compared to the predicate device's reported performance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a test set from a clinical study for the device, as this is a device clearance based on substantial equivalence to a predicate, heavily relying on non-clinical performance data and conformity to recognized standards.
- For Freedom from pinholes, the subject device reported 0/200, implying a sample size of 200 gloves tested for pinholes. The predicate device reported 10/500, implying a sample size of 500 gloves.
- For Powder residual, the measurement is "0.5mg per glove," which would typically be an average or maximum over a sampled number of gloves, but the specific sample size for this test is not provided.
- Biocompatibility testing (Cytotoxicity, Sensitization, Irritation) involved testing samples of the subject device. The specific number of samples tested for these biocompatibility evaluations is not mentioned in the provided text.
Data Provenance: The document does not specify the country of origin for the testing data, but the manufacturer is based in China. The data would be retrospective relative to the 510(k) submission, as it represents tests already conducted to support the filing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the device is a medical glove, and the evaluation relies on objective physical and chemical testing against established standards, not on expert interpretation of results like in diagnostic imaging. Ground truth for these types of devices is based on laboratory measurements and adherence to specified performance metrics.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation is based on objective laboratory testing against performance standards, which does not involve subjective adjudication or consensus methods typically seen in clinical studies with human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This device is a patient examination glove, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is irrelevant and not part of the submission for this type of device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This is a physical medical device (glove), not an algorithm or software. Therefore, a standalone performance study in the context of AI algorithms is not relevant.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Standardized laboratory measurements: Adherence to physical properties (length, width, thickness, tensile strength, elongation), freedom from pinholes, and powder residual, as defined by ASTM standards (D5250-06, D5151-06, D6124-06).
- Biocompatibility testing results: Based on ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation), assessing the biological response of the device material.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply here.
§ 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.