(100 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). PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
This document is a 510(k) Premarket Notification summary for "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)" by Shijiazhuang Richful Plastic Co.,Ltd. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against acceptance criteria in the context of an AI/software device.
Therefore, many of the requested categories (e.g., multi-reader multi-case study, effect size of human reader improvement with AI, standalone performance, training set details) are not applicable to this type of device and submission.
However, I can extract the acceptance criteria and performance as presented for this specific medical device.
Acceptance Criteria and Device Performance for Powder Free Vinyl Patient Examination Gloves
| Feature/Test | Acceptance Criteria (Predicate/New Device) | Reported Device Performance (New Device) |
|---|---|---|
| Dimensions - Length | Meets ASTM D5250-06 (Reapproved 2011), ≥230mm min. | Meets ASTM D5250-06 (Reapproved 2011), 230mm min for all sizes |
| Dimensions - Width | Meets 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 84-87mm, Medium 94-97mm, Large 103-106mm, X large 113-115mm |
| Dimensions - Thickness | Meets 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) | Meets ASTM D5250-06 (Reapproved 2011). Elongation ≥300%, Tensile Strength ≥11MPa | Meets ASTM D5250-06 (Reapproved 2011). Elongation ≥300%, Tensile Strength ≥11MPa |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06 (Reapproved 2011), and ASTM D 5151-06 (Reapproved 2011). AQL 2.5 (Inspection Level I) | Meets ASTM D5151-06 (Reapproved 2011). Holes: Inspection Level I, AQL 2.5 |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011). | Meets ASTM D6124-06 (Reaffirmation 2011). Results generated values below 2mg of residual powder |
| Biocompatibility (Skin Irritation/Sensitization) | Meets ISO 10993-10:2002/Amd.1:2006 (Predicate), Meets ISO 10993-10 Third Edition 2010-08-01 (Subject Device) | Test article was a non-irritant or non-sensitizer. |
Study Information (as applicable to this device type):
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Sample size used for the test set and the data provenance:
- The document refers to standard ASTM methods (D5250-06, D5151-06, D6124-06) and ISO 10993-10 for testing. These standards specify sampling plans, but the exact sample sizes used for this specific submission's tests are not explicitly stated within the provided text.
- Data Provenance: The testing appears to be based on the manufacturing and testing done by Shijiazhuang Richful Plastic Co.,Ltd. in China. The nature of these tests (e.g., batch release testing, dedicated validation studies) suggests they are prospective, performed to demonstrate compliance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for this type of device (patient examination gloves). The "ground truth" for performance is established by objective physical and chemical testing against established standards (ASTM, ISO), not by expert interpretation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Objective physical tests do not require adjudication.
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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:
- This is not applicable as this device is not an AI/software device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable as this device is not an AI/software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on objective measurements compared against established industry standards (ASTM D5250, ASTM D5151, ASTM D6124) and biocompatibility standards (ISO 10993-10). For example, a glove either meets the minimum tensile strength requirement or it doesn't, based on machine testing.
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The sample size for the training set:
- This is not applicable as this device is not an AI/software device. There is no "training set."
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How the ground truth for the training set was established:
- This is not applicable as this device is not an AI/software 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.