(171 days)
Nitrile Powder Free Patient Examination Gloves, Blue 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.
This document describes the acceptance criteria and performance of the "Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color" (K152720) in comparison to a predicate device (K120970) to establish substantial equivalence for FDA 510(k) clearance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard / Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Dimension | ASTM standard D 6319-10. | Meets | Meets |
| Length | ≥ 230mm min (ASTM D6319-10) | 230mm min for all sizes | Substantially Equivalent |
| Width (Small) | 70-90 mm (ASTM D6319-10) | 84-85 mm | Substantially Equivalent |
| Width (Medium) | 85-105 mm (ASTM D6319-10) | 94-96 mm | Substantially Equivalent |
| Width (Large) | 100-120 mm (ASTM D6319-10) | 105-107 mm | Substantially Equivalent |
| Width (X-Large) | 110-130 mm (ASTM D6319-10) | 115-118 mm | Substantially Equivalent |
| Thickness (Finger) | 0.05mm min (ASTM D6319-10) | 0.10 mm min. | Substantially Equivalent |
| Thickness (Palm) | 0.05mm min (ASTM D6319-10) | 0.06 mm min. | Substantially Equivalent |
| Physical Properties | ASTM standard D 6319-10. | Meets | Meets |
| Elongation (Before/After aging) | ≥ 500% (ASTM D6319-10) | 520-580% | Substantially Equivalent |
| Tensile Strength (Before/After aging) | ≥ 14MPa (ASTM D6319-10) | 22-34 MPa | Substantially Equivalent |
| Freedom from Pinholes | 21 CFR 800.20, ASTM D6319-10, ASTM D5151-06 (Reapproved 2011) | Meets (Holes at Inspection Level I AQL2.5) | Meets / Substantially Equivalent |
| Powder Residual | ASTM D6319-10 and D6124-06 (Reapproved 2011) | Meets, |
§ 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.