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510(k) Data Aggregation
(79 days)
Powder Free Vinyl 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.
PVC films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. Its 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.
The provided text is an FDA 510(k) summary for "Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a medical device's performance against specific clinical efficacy or diagnostic accuracy criteria as would be required for a novel AI/imaging device.
Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, effect size, type of ground truth) are not applicable to this type of medical device submission. This submission relies on established performance standards for examination gloves.
Here's how the available information from the document applies to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document compares the subject device's performance against established ASTM standards and FDA requirements, as well as against the predicate device.
| Characteristics | Standard / Acceptance Criteria | Predicate Device Reported Performance (K091663) | Subject Device Reported Performance (K173017) | Result of Comparison |
|---|---|---|---|---|
| Dimension | ASTM D5250-06 (Reapproved 2011) | |||
| Length | ≥ 230mm | 231-241mm (Range) | 232-241mm (Range) | Same |
| Width (Small) | 80-90 mm | 81-89 mm (Range) | 82-88 mm (Range) | Same |
| Width (Medium) | 90-100mm | 93-99 mm (Range) | 93-98 mm (Range) | Same |
| Width (Large) | 100-110mm | 102-110 mm (Range) | 102-108 mm (Range) | Same |
| Width (X Large) | 110-120 mm | 111-119 mm (Range) | 113-118 mm (Range) | Same |
| Thickness (Fingertip) | ≥ 0.05mm | 0.05-0.10mm (Range) | 0.08-0.11mm (Range) | Same |
| Thickness (Palm) | ≥ 0.08mm | 0.09-0.13mm (Range) | 0.10-0.12mm (Range) | Same |
| Physical Properties | ASTM D5250-06 (Reapproved 2011) | |||
| Elongation (Before & After aging) | ≥ 300% | 340-410% (Range) | 350-420% (Range) | Same |
| Tensile Strength (Before & After aging) | ≥ 11MPa | 15-25 MPa (Range, specified as "> 14MPa" for predicate) | 15-20 MPa (Range) | Same |
| Freedom from Pinholes | 21 CFR 800.20 Passed Standard Acceptance Criteria; ASTM D5250-06; ASTM D5151-06 | Meets ASTM D5151-06 (Reapproved 2011), ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011), ASTM D5250-06 (Reapproved 2011) | Same (Holes at Inspection Level IAQL2.5) |
| Powder Residual | **ASTM D5250-06 (Reapproved 2011), ASTM D6124-06 (Reaffirmation 2011) Meets |
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