(341 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Thermoplastic Elastomer (TPE) Hybrid Examination Glove is a patient examination glove made from polyethylene resin and styrene-ethylene-styrene (SEBS) compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device 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 D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Thermoplastic Elastomer (TPE) Hybrid Examination Glove:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Test Method | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|---|
| Dimension | ASTM D3767 | Determine the geometrical dimension of gloves | Length: 230 mm min. | |
| Thickness: Palm - 0.05 mm min., Finger - 0.05 mm min. | ||||
| Palm Width: Small 104 ± 5 mm, Medium 107 ± 5 mm, Large 115 ± 5 mm, X large 123 ± 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 aging/After aging) | ASTM D412-16 & ASTM D573-04 | Evaluate the tensile properties of the gloves and the influence of elevated temperature. | Before Aging: 14 MPa, min. | |
| After Aging: 14 MPa, min. | Pass | |||
| Elongation (Before aging/After aging) | ASTM D412-16 & ASTM D573-04 | Evaluate the elongation properties of the gloves and the influence of elevated temperature. | Before Aging: 500% min. | |
| After Aging: 400% min. | Pass | |||
| Powder Residual | ASTM D6124-06 | Determine the average powder mass found on the gloves |
§ 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.