(49 days)
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color 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.
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.
The provided document describes a 510(k) premarket notification for Kindguard Powder Free Vinyl Patient Examination Gloves. This is a Class I medical device, and the evaluation for substantial equivalence primarily relies on non-clinical performance data and comparison to a predicate device, rather than a study involving an AI algorithm or human readers.
Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets those criteria (especially those related to AI, human readers, ground truth establishment, sample sizes for training/test sets, and expert adjudication) are not applicable to this type of device and submission.
However, I can extract the relevant information regarding the acceptance criteria and the performance of this specific device based on the provided text.
Here's a breakdown of the requested information, with NA (Not Applicable) for elements not relevant to this submission type:
Acceptance Criteria and Device Performance for Kindguard Powder Free Vinyl Patient Examination Gloves
This submission is for a Class I medical device (patient examination gloves), which does not involve an AI algorithm or complex human interpretation tasks. Thus, the "study" proving acceptance is primarily a set of non-clinical performance tests and a comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard/Acceptance Criteria | Reported Device Performance (Kindguard Gloves) | Comparison Result |
|---|---|---|---|
| Form Factor / Dimensions | |||
| Length | ≥230mm (ASTM D 5250-06) | 231-241mm (Small, Medium, Large, X-Large) | Similar |
| Width (Small) | 80-90 mm (ASTM D 5250-06) | 81-89mm | Similar |
| Width (Medium) | 90-100 mm (ASTM D 5250-06) | 93-99mm | Similar |
| Width (Large) | 100-110 mm (ASTM D 5250-06) | 102-110mm | Similar |
| Width (X-Large) | 110-120 mm (ASTM D 5250-06) | 111-119mm | Similar |
| Thickness (Fingertip) | ≥0.05mm (ASTM D 5250-06) | 0.05-0.10mm | Similar |
| Thickness (Palm) | ≥0.08mm (ASTM D 5250-06) | 0.09-0.13mm | Similar |
| Physical Properties | |||
| Tensile Strength (Before & After aging) | ≥11MPa (ASTM D 5250-06) | 15-25 MPa (Before & After aging) | Same |
| Elongation Rate (Before & After aging) | ≥300% (ASTM D 5250-06) | 340-410% (Before & After aging) | Same |
| Freedom from Pinholes | Passed Standard Acceptance Criteria (21 CFR 800.20, ASTM D5250-06, ASTM D5151-06) | Holes at Inspection Level I, AQL2.5 | Passed / Same |
| Powder Residual |
§ 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.