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510(k) Data Aggregation
(181 days)
Powder Free Nitrile Patient Examination Gloves, Black Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
The provided document is a 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Black Color". It details the device's characteristics and compares it to a predicate device to establish substantial equivalence.
Here's the information about the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 6319-10 (e.g., Length ≥230mm min for all sizes) | Meets (e.g., Length 230mm min for all sizes, Width values are provided and specific) |
| Physical Properties | ASTM standard D 6319-10 (e.g., Elongation ≥500%, Tensile Strength ≥14MPa) | Meets (e.g., Elongation: 520-620%, Tensile Strength: 20-36 MPa) |
| Freedom from Pinholes | 21 CFR 800.20, ASTM D 5151-06 (Reapproved 2011) (Inspection Level I, AQL 2.5) | Meets (Holes at Inspection Level I, AQL 2.5) |
| Powder Residual | ASTM standard D 6319-10 and D6124-06 (Reapproved 2011) ( |
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