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510(k) Data Aggregation
(402 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Nitrile Patient Examination Gloves, Powder Free, Pink Color. The subject device is a patient examination glove made from nitrile compound, pink color, powder free and non-sterile (Per 21 CFR 880.6250, class I). These gloves are pink in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL).
The provided text describes the acceptance criteria and the study results for the "Nitrile Patient Examination Gloves, Powder Free, Pink Color" manufactured by Shandong YINGHONG Medical Products Co., Ltd.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method (Purpose) | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Dimensions (length, width, thickness) (ASTM D6319-19) - To evaluate the physical dimension of the glove | Length: 220 mm min (XS, S); 230 mm min (M, L, XL, XXL) | Pass (240 mm min) |
| Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10; XXL: 130±10 | Pass (XS: average 78.4mm; S: average 86.2mm; M: average 97.4mm; L: average 108.7mm; XL: average 115.5mm; XXL: average 123.5mm) | |
| Thickness(mm): Palm: Minimum 0.05; Finger: Minimum 0.05 | Pass (Palm - 0.056mm min.; Finger - 0.082mm min) | |
| Physical properties (ASTM D6319-19) - To evaluate the tensile strength and ultimate elongation before and after aging | Before Aging: Tensile Strength: 14 MPa, min.; Elongation: 500%, min. | |
| After Aging: Tensile Strength: 14 MPa, min.; Elongation: 400%, min. | Pass (Before Aging: Tensile Strength: 20.6MPa, min.; Elongation: 531%, min. | |
| After Aging: Tensile Strength: 21.9MPa, min.; Elongation: 416%, min.) | ||
| Freedom from holes (ASTM D5151-19) - To detect holes in the gloves | In accordance with ASTM D6319-19 and ASTM D5151-19, G-1, AQL 2.5 (Implicit in "Similar" comparison to predicate) | (The specific result for this test is not explicitly stated in the table provided for the subject device, but the comparison table indicates "Similar" to the predicate which met these standards) |
| Residual Powder (ASTM D6124-06) - To detect the powder residue in the glove |
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