(323 days)
Powder Free Viny! Patient Examination Gloves, Clear (Non-colored) 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.
Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011). PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC 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. PVC gloves are 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 D5250 and ASTM D5151 requirements.
The provided text is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)." This type of regulatory submission demonstrates substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a study with the detailed elements requested.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable in this context. The submission focuses on demonstrating that the new device has technological characteristics and performance that are equivalent to a legally marketed predicate device and complies with recognized standards.
Here's the information that can be extracted and a clear indication of what is not applicable:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Standard Requirement) | Reported Device Performance (Compliance) |
|---|---|
| Dimensions - Length (ASTM D5250-06 (Reapproved 2011) >230mm min.) | Subject Device: 230mm min for all sizes (Substantially equivalent) |
| Dimensions - Width (ASTM D5250-06 (Reapproved 2011)) | Subject Device: Small 80-85 mm, Medium 95-97 mm, Large 102-108mm, X large 114-118 mm (These specific ranges are within the acceptable ranges of ASTM D5250-06, making it Substantially equivalent) |
| Dimensions - Thickness (ASTM D5250-06 (Reapproved 2011) Finger 0.05mm min., Palm 0.08mm min.) | Subject Device: Finger 0.05mm min., Palm 0.08mm min. (Substantially equivalent) |
| Physical Properties - Elongation (ASTM D5250-06 (Reapproved 2011) ≥300%) | Subject Device: Elongation ≥300% (Substantially equivalent) |
| Physical Properties - Tensile Strength (ASTM D5250-06 (Reapproved 2011) >14MPa) | Subject Device: Tensile Strength > 14MPa (Substantially equivalent) |
| Freedom from Pinholes (21 CFR 800.20, ASTM D5250-06, ASTM D5151-06; AQL 2.5 for Holes at Inspection Level I) | Subject Device: Meets ASTM D5151-06 (Reapproved 2011), Holes Inspection Level I AQL 2.5 (Substantially equivalent) |
| Residual Powder (ASTM D6124-06 (Reapproved 2011) |
§ 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.