(60 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner. 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. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
This document pertains to the 510(k) premarket notification for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). The information provided heavily focuses on proving substantial equivalence to a predicate device through non-clinical performance data, primarily compliance with established ASTM and ISO standards for medical gloves.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 5250-06 (Reapproved 2015) | Met ASTM D 5250-06 (Reapproved 2015) |
| Length | ≥230mm | Subject Device: 231-241mm (Predicate: 231-242mm) - Stated as "Similar" |
| Width (Small) | 80-90 mm | Subject Device: 81-89mm (Predicate: 82-89mm) - Stated as "Similar" |
| Width (Medium) | 90-100mm | Subject Device: 93-99mm (Predicate: 93-99mm) - Stated as "Similar" |
| Width (Large) | 100-110mm | Subject Device: 102-110mm (Predicate: 103-109mm) - Stated as "Similar" |
| Width (X-Large) | 110-120 mm | Subject Device: 111-119mm (Predicate: 114-119mm) - Stated as "Similar" |
| Thickness (Fingertip) | ≥0.05mm | Subject Device: 0.09-0.10mm (Predicate: 0.05-0.10mm) - Stated as "Similar" |
| Thickness (Palm) | ≥0.08mm | Subject Device: 0.10-0.11mm (Predicate: 0.09-0.13mm) - Stated as "Similar" |
| Physical Properties | ASTM D 5250-06 (Reapproved 2015) | Met ASTM D 5250-06 (Reapproved 2015) |
| Tensile Strength | ≥11MPa (Before & After aging) | Subject Device: 15-22 MPa (Predicate: 16-20 MPa) - Stated as "Similar" |
| Elongation Rate | ≥300% (Before & After aging) | Subject Device: 350-420% (Predicate: 380-410%) - Stated as "Similar" |
| Freedom from Pinholes | 21 CFR 800.20 | |
| ASTM D5250-06 (Reapproved 2015) | ||
| ASTM D5151-19 | ||
| Holes at Inspection Level I AQL2.5 | Subject Device: "Passed Standard Acceptance Criteria" | |
| Holes at Inspection Level I AQL2.5 (Same as predicate) | ||
| Powder Residual | ASTM D5250-06 (Reapproved 2015) | |
| ASTM D6124-06 (Reapproved 2017) |
§ 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.