(240 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color 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.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
The provided text is a 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color," which is a Class I medical device. This type of device does not typically involve complex algorithms or AI; instead, its performance is evaluated based on physical characteristics and material biocompatibility against established standards. Therefore, the requested information regarding AI-specific evaluation criteria (like multi-reader multi-case studies, expert adjudication, AI effect size, training set details) is not applicable to this submission.
Here's a breakdown of the acceptance criteria and study information that is relevant and available in the document:
1. A table of acceptance criteria and the reported device performance
| Feature/Test | Acceptance Criteria (Predicate or Standard) | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| Dimensions - Length (ASTM D6319-10) | ≥230mm min | 232 mm min for all sizes | Similar |
| Dimensions - Width (ASTM D6319-10) | Small: 70-90mm | ||
| Medium: 85-105mm | |||
| Large: 100-120mm | |||
| X large: 110-130mm | Small: 76-90 mm | ||
| Medium: 87-102 mm | |||
| Large: 108-119mm | |||
| X large: 115-128 mm | Similar | ||
| Dimensions - Thickness (ASTM D6319-10) | Finger: 0.05mm min. | ||
| Palm: 0.05mm min. | Fingertip: ≥0.08mm | ||
| Palm: ≥0.08mm | Similar | ||
| Physical Properties - Tensile Strength (Before & After aging) (ASTM D6319-10) | ≥ 14MPa | Before Aging: 18-25 MPa | |
| After Aging: 17-22 MPa | Similar | ||
| Physical Properties - Elongation (Before aging) (ASTM D6319-10) | ≥500% | Before Aging: 550-610% | Similar |
| Physical Properties - Elongation (After aging) (ASTM D6319-10) | ≥400% | After Aging: 450-570% | Similar |
| Freedom from Pinholes (21 CFR 800.20, ASTM D6319-10) | Inspection Level I AQL2.5; Accept/Reject criteria of 10/11 (Predicate) | Water leakage test: 5 noncompliance is allowed. | Similar |
| Residual Powder (ASTM D6124-06) | Below 2mg of residual powder | Mean: 0.1mg/pcs | Pass |
| Biocompatibility - Primary Skin Irritation (ISO 10993-10:2010) | Non-irritant | Under the conditions of the study, the subject device is not a primary skin irritant. | Passes |
| Biocompatibility - Dermal Sensitization (ISO 10993-10:2010) | Non-sensitizer | Under the conditions of the study, the subject device is not a skin sensitizer. | Passes |
| Biocompatibility - Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxicity to L-929 cells | Under the conditions of this study, the test article was non-cytotoxicity to L-929 cells. | Pass |
| Biocompatibility - Acute Systemic Toxicity (ISO 10993-11:2017) | No systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern. | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each physical test. However, it indicates general inspection levels where applicable, such as "ILS-2 AQL4.0" for dimensions and "Inspection Level I AQL2.5" for freedom from pinholes. For residual powder, it states "Checked on 5pcs sub-samples (N=5)."
The provenance of the data is from non-clinical laboratory testing performed by the manufacturer to demonstrate compliance with relevant ASTM and ISO standards. The document does not specify the country of origin of the raw data, but the manufacturer is Shandong Shangwei Medical Products Co.,Ltd, located in China. The studies are prospective in nature, as they are specifically conducted to test the performance of the device against predefined criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device is based on objective measurements against established international and national standards (ASTM, ISO, CFR) for physical properties and biocompatibility. It does not involve expert interpretation or subjective assessment of medical images or patient conditions.
4. Adjudication method for the test set
Not applicable. As described above, this is not an AI or diagnostic device requiring expert adjudication. Test results are quantitative measurements compared against predefined thresholds in standards.
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 patient examination glove and does not involve AI or human "readers" in a diagnostic capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm for this device.
7. The type of ground truth used
The ground truth used for this device's evaluation is based on established industry standards and objective laboratory measurements. These include:
- ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) for dimensions and physical properties.
- 21 CFR 800.20 and ASTM D5151-19 for freedom from pinholes.
- ASTM D6124-06 for residual powder.
- ISO 10993-5, ISO 10993-10, and ISO 10993-11 for biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity).
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.