(86 days)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
Based on the provided document, the device in question is a Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile. This is not a medical imaging AI device or a diagnostic AI device. The document is a 510(k) Premarket Notification summary for a medical glove, which is a physical device, and the testing conducted is for physical and chemical properties, not algorithmic performance.
Therefore, the requested information, which pertains to the acceptance criteria and study designs for AI/ML device performance (e.g., sample size for test set, expert ground truth, MRMC studies, standalone performance, training set details), is not applicable to this document.
The document describes non-clinical testing for the glove, focusing on properties like tensile strength, elongation, dimensions, watertight integrity, residual powder, and biocompatibility.
However, I can extract and present the acceptance criteria and performance data as per the document's content, formatted as a table, making it clear that this applies to a physical device and not an AI/ML system.
Acceptance Criteria and Device Performance for Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile (K222720)
The following table summarizes the non-clinical acceptance criteria and the reported performance of the device. It's crucial to understand that this concerns the physical and chemical properties of a medical glove, not the performance of an AI/ML algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Test Method | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Physical Properties | ||||
| Tensile Strength | ASTM D412 | Before Aging: Min 14.0 MPa | Before Aging: XS - 28.1 MPa, S - 28.4 MPa, M - 29.2 MPa, L - 28.0 MPa, XL - 28.9 MPa | Pass |
| After Aging: Min 14.0 MPa | After Aging: XS - 31.2 MPa, S - 30.9 MPa, M - 32.3 MPa, L - 31.0 MPa, XL - 31.3 MPa | Pass | ||
| Ultimate Elongation | ASTM D412 | Before Aging: Min 500% | Before Aging: XS - 540%, S - 530%, M - 550%, L - 540%, XL - 540% | Pass |
| After Aging: Min 400% | After Aging: XS - 460%, S - 460%, M - 470%, L - 490%, XL - 480% | Pass | ||
| Dimensions | ASTM D3767 | |||
| Length (all sizes) | Min 240 mm | XS - 244 mm, S - 242 mm, M - 242 mm, L - 243 mm, XL - 244 mm | Pass | |
| Width | XS: $70 \pm 10$ mm; S: $80 \pm 10$ mm; M: $95 \pm 10$ mm; L: $110 \pm 10$ mm; XL: $120 \pm 10$ mm | XS - 74.0 mm, S - 85.0 mm, M - 95.0 mm, L - 106 mm, XL - 115 mm | Pass | |
| Thickness (Finger) | Min 0.05 mm | All sizes (XS, S, M, L, XL) - 0.10 mm | Pass | |
| Thickness (Palm) | Min 0.05 mm | All sizes (XS, S, M, L, XL) - 0.06 mm | Pass | |
| Watertight Integrity | ASTM D5151 | AQL 1.5, Acceptance No. 10 (for sample size 315 pcs) | For sample size 315 pcs (batch size 150,001 to 500,000): XS - 4 leaks, S - 2 leaks, M - 3 leaks, L - 1 leak, XL - 2 leaks. All within acceptance criteria. | Pass |
| Residual Powder | ASTM D6124 | Less than 2 mg per glove ( |
§ 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.