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510(k) Data Aggregation
(84 days)
Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Nitrile Examination Gloves. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I) for single use only. The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The document describes the acceptance criteria and study results for "Nitrile Examination Gloves" (K212551). The device is a non-sterile, powder-free, single-use patient examination glove made from nitrile compound.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Dimensions (ASMT D6319-19) | To determine the width, length, and thickness of the gloves | Width: | |
| 80mm ±10mm (small) | |||
| 95mm ±10mm (medium) | |||
| 110 mm ±10mm (large) | |||
| Length: | |||
| 220mm (Min) (small) | |||
| 230 mm (Min) (medium, large) | |||
| Thickness: | |||
| Finger - 0.05 mm (Min) | |||
| Palm - 0.05 mm (Min) | Width: | ||
| small size: 81 to 89mm | |||
| medium size: 91 to 98mm | |||
| large size: 109 to 111mm | |||
| Length: | |||
| small size: 230mm (minimum) | |||
| medium size: 240mm (minimum) | |||
| large size: 244mm (minimum) | |||
| Thickness: | |||
| Finger: small size: 0.12mm (minimum), medium size: 0.13mm (minimum), large size: 0.13mm (minimum) | |||
| Palm: small size: 0.08mm (minimum), medium size: 0.08mm (minimum), large size: 0.08mm (minimum) | |||
| Result: Passed | |||
| Physical Requirements (ASMT D6319-19) | To determine tensile strength and ultimate elongation before and after acceleration aging | Before Acceleration Aging: | |
| Tensile Strength (MPa): 14 (Minimum) | |||
| Ultimate Elongation (%): 500 (Minimum) | |||
| After Acceleration Aging: | |||
| Tensile Strength (MPa): 14 (Minimum) | |||
| Ultimate Elongation (%): 400 (Minimum) | Before Acceleration Aging: | ||
| Tensile Strength (MPa): 26 (Minimum) | |||
| Ultimate Elongation (%): 538 (Minimum) | |||
| After Acceleration Aging: | |||
| Tensile Strength (MPa): 25 (Minimum) | |||
| Ultimate Elongation (%): 511 (Minimum) | |||
| Result: Passed | |||
| Freedom from Holes (ASTM D6319-19 (ASTM D5151-11)) | To determine the holes in the gloves | AQL 2.5 | Result: Passed |
| Residual Powder (ASMT D6319-19 (ASTM D6124-11)) | To determine the residual powder in the gloves |
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