(170 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.
The provided document is a 510(k) summary for the Nitrile Powder Free Patient Examination Gloves, Blue Color (K152712). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a novel device meets specific acceptance criteria through a clinical study involving AI or human readers.
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Acceptance Criteria and Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM standard D 6319-10. | Meets |
| Dimensions - Length | ASTM D6319-10 ≥230mm min | Meets ASTM D6319-10 ≥230mm min for all sizes |
| Dimensions - Width | ASTM D6319-10 Small: 70-90 mm; Medium: 85-105mm; Large: 100-120mm; Xlarge: 110-130 mm | Meets ASTM D6319-10 Small: 70-90mm; Medium: 85-105mm; Large: 100-120mm; Xlarge: 110-130mm |
| Dimensions - Thickness | ASTM D6319-10 Finger: 0.05mm min.; Palm: 0.05mm min. | Meets ASTM D6319-10 Finger: 0.05mmmin.; Palm: 0.05mmmin. |
| Physical Properties | ASTM standard D 6319-10. | Meets |
| Physical Properties (Elongation & Tensile Strength) | ASTM D D6319-10 Before aging/after aging Elongation ≥500%; Tensile Strength ≥ 14MPa | Meets ASTM D D6319-10 Before aging/after aging Elongation ≥500%; Tensile Strength ≥ 14MPa |
| Freedom from pinholes | 21 CFR 800.20; ASTM D6319-10; ASTM D 5151-06 (Reapproved 2011) | Meets; Holes at Inspection Level I AQL 2.5 |
| Powder Residual | ASTM standard D 6319-10 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.