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510(k) Data Aggregation
(216 days)
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
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 Disposable Powder Free Vinyl Examination Gloves (with color Beige or Clear) is a patient examination glove made from poly (vinvl chloride), non-sterile (as per 21 CFR 880.6250, Class I). The operation principle of this medical device is to provide single use barrier protection for the wearer and the device meets all the requirement specifications for barrier protection, tensile properties as defined in ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
The document provides information about the non-clinical performance evaluation of "Disposable Powder Free Vinyl Examination Gloves, Beige/Clear" to demonstrate its substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Dimension | ASTM D3767 | Determine the geometrical dimension of gloves | Length: 230 mm min. | Pass |
| Thickness: Palm - 0.08 mm min., Finger - 0.08 mm min. | Pass | |||
| Palm Width: Small 85 ± 5 mm, Medium 95 ± 5 mm, Large 105 ± 5 mm, X Large 115 ± 5 mm | Pass | |||
| Freedom from holes (Water leak) | 21 CFR 800.20. & ASTM D5151-19 | Detect the holes on the gloves. | G-I/AQL 2.5 | Pass |
| Tensile strength (Before/After aging) | ASTM D412-16 & ASTM D573-04 | Evaluate the tensile (tension) properties of the gloves. In addition, it also determines the influence of elevated temperature on the physical properties of gloves. | Before Aging: 11 MPa, min. | Pass |
| After Aging: 11 MPa, min. | Pass | |||
| Elongation (Before/After aging) | ASTM D412-16 & ASTM D573-04 | (purpose as above for tensile strength) | Before Aging: 300% min. | Pass |
| After Aging: 300% min. | Pass | |||
| Powder Residual | ASTM D6124-06 | Determine the average powder mass found on the gloves |
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(63 days)
DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES
A patient examination glove is a disposable device intended to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Examination Gloves
The provided document is a 510(k) premarket notification letter from the FDA to a manufacturer of disposable powder-free vinyl examination gloves. It states that the device is substantially equivalent to legally marketed predicate devices.
This document does not contain information about acceptance criteria, device performance studies, or ground truth establishment for an AI/device. It is a regulatory approval letter for a simple medical device (gloves) and does not involve AI or complex performance metrics beyond basic safety and effectiveness for its intended use (preventing contamination).
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is absent from the provided text.
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