(56 days)
The Vinyl Examination Gloves(Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.
This FDA 510(k) summary is for a Vinyl Examination Glove and does not describe an AI/ML powered medical device. Therefore, it does not include the detailed information typically associated with such device evaluations, such as studies on acceptance criteria, reader performance, or ground truth establishment.
However, I can extract the acceptance criteria and performance data for this traditional medical device based on the provided document.
Acceptance Criteria and Device Performance (Vinyl Examination Gloves):
The acceptance criteria are primarily defined by adherence to recognized international and national standards for medical gloves, and comparability to the predicate device. The performance data is presented in the context of these standards and comparisons.
| Acceptance Criteria Item | Standard/Requirement | Reported Device Performance | Comparison to Predicate Device |
|---|---|---|---|
| Physical Dimensions | Length: Based on predicate device (K163168) with specific tolerance | Subject Device (K203702): Length, mm (S, M, L, XL): 240, 240, 240, 240 (±10) | |
| Predicate Device (K163168): Length, mm (XS, S, M, L, XL): 230, 230, 235, 245, 245 (min) | Similar | ||
| Width: Based on predicate device (K163168) with specific tolerance | Subject Device (K203702): Width, mm (S, M, L, XL): 85, 95, 105, 115 (±5) | ||
| Predicate Device (K163168): Width, mm (XS, S, M, L, XL): 80, 85, 95, 105, 115 (±5) | Similar | ||
| Thickness (Finger): Based on predicate device with specific tolerance | Subject Device (K203702): Finger, mm: 0.10 (±0.05) | ||
| Predicate Device (K163168): Finger, mm: 0.05 (min) | Similar | ||
| Thickness (Palm): Based on predicate device with specific tolerance | Subject Device (K203702): Palm, mm: 0.08 (min) | ||
| Predicate Device (K163168): Palm, mm: 0.08 (min) | Similar | ||
| Physical Properties | Comply with ASTM D5250 (Standard Specification for Poly (vinyl chloride) Gloves for Medical Application) | Comply with ASTM D5250 | Same |
| Before Aging Tensile Strength | Specified by ASTM D5250 and comparable to predicate | Subject Device: 11MPa, min | |
| Predicate Device: 15MPa, min | Similar (meets ASTM D5250) | ||
| Before Aging Ultimate Elongation | Specified by ASTM D5250 and comparable to predicate | Subject Device: 300%min | |
| Predicate Device: 380%min | Similar (meets ASTM D5250) | ||
| After Aging Tensile Strength | Specified by ASTM D5250 and comparable to predicate | Subject Device: 11MPa, min | |
| Predicate Device: 15MPa, min | Similar (meets ASTM D5250) | ||
| After Aging Ultimate Elongation | Specified by ASTM D5250 and comparable to predicate | Subject Device: 300%min | |
| Predicate Device: 380%min | Similar (meets ASTM D5250) | ||
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Same |
| Powder Content | Comply with ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) | Subject Device: 0.01 mg per glove | |
| Predicate Device: Meet the requirements of ASTM D6124 | Similar | ||
| Biocompatibility | Irritation: Not an irritant (ISO 10993-10) | Under the conditions of the study, not an irritant | Same |
| Sensitization: Not a sensitizer (ISO 10993-10) | Under conditions of the study, not a sensitizer. | Same | |
| Cytotoxicity: No potential toxicity to L-929 cells (ISO 10993-5) | Under conditions of the study, did not show potential toxicity to L-929 cells. | Different (lack of predicate data) | |
| Material | Vinyl | Vinyl | Same |
| Labeling | Meet FDA's Requirement | Meet FDA's Requirement (Single use, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile) | Similar |
Since this document is for a traditional medical device (Vinyl Examination Gloves) and not an AI/ML powered device, the following points are not applicable or the information is not provided in the document:
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Sample size used for the test set and the data provenance: The document mentions "test results" for physical and biological properties, but it does not specify the sample size for these tests. The provenance of the data is implied to be from the manufacturer (XINYING TRADING CO.,LTD.) in China, for the device manufactured there.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device. Ground truth is established by standardized testing protocols (e.g., ASTM, ISO) and laboratory results, not expert consensus in the clinical sense.
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Adjudication method: Not applicable. Performance is based on objective measurements against established standards.
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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 as this is not an AI/ML-powered device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is not an AI/ML-powered device.
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The type of ground truth used: The "ground truth" for this device's performance is derived from compliance with recognized performance standards (ASTM D5250, ASTM D5151, ASTM D6124) and biocompatibility standards (ISO 10993-10, ISO 10993-5) through laboratory testing.
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The sample size for the training set: Not applicable as this is not an AI/ML-powered device requiring a training set.
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How the ground truth for the training set was established: Not applicable as this is not an AI/ML-powered device requiring a training set.
Summary of the Study that Proves Acceptance Criteria:
The study proving the device meets the acceptance criteria is detailed in the "Non-Clinical Test Conclusion" (Section 8.0). The device was tested for compliance with the following standards:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization: This standard was used to demonstrate that the glove is not an irritant or sensitizer.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity: This standard was used to show that the glove did not exhibit potential toxicity to L-929 cells.
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves: This standard confirms the powder content within acceptable limits for a powder-free glove.
- ASTM D5151-06 (Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves: This standard ensures the integrity of the gloves (freedom from holes).
- ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application: This is a comprehensive standard covering general physical requirements such as tensile strength, ultimate elongation, and dimensions.
The document states that the "test results demonstrated that the proposed device complies with the following standards," suggesting that the performance metrics listed in Table 3 and Table 4 were obtained through testing against these specified standards. The comparison to the predicate device (Hebei Hongtai Plastic Products Company Limited's Vinyl Patient Examination Gloves K163168) further supports the substantial equivalence claim by showing similar technological characteristics and performance within the established standards, even with some numerical differences in physical properties like tensile strength and elongation, which were deemed to still meet ASTM D5250 and thus not raise new safety or performance questions. Clinical testing was not deemed necessary for this device (Section 9.0).
§ 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.