(219 days)
Powder Free Nitrile 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.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is non-sterile and disposable medical glove intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is made of nitrile butadiene rubber (NBR), as per standard meets ASTM D6319-10(Reapproved 2015).
The proposed device is Powder Free Nitrile Examination and variants of different sizes, such as size S/M/L/XL. All variants share the same color, blue.
The provided text describes the 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color" (K211864). This document primarily focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device. It specifically states that "Clinical testing is not needed for this device." Therefore, the requested information pertaining to AI/ML device studies, such as multi-reader multi-case studies, expert adjudication, training/test set ground truth establishment, or sample sizes for AI model development, is not applicable to this submission.
The document outlines the acceptance criteria and reported device performance based on non-clinical tests.
Here is the table summarizing the acceptance criteria and stated performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D 6319-06 (Reapproved 2015) | Dimension Length | ≥ 230mm | 237 mm min for all sizes | Pass |
| Dimension Width | Small 70-90 mm | 85-87 mm | Pass | |
| Medium 85-105mm | 95-97 mm | Pass | ||
| Large 100-120mm | 105-107mm | Pass | ||
| X large 110-130 mm (from comparison table) | 115-117 mm (from comparison table) | Pass | ||
| Thickness | Fingertip ≥ 0.05 mm | 0.091mm | Pass | |
| Palm ≥ 0.05 mm | 0.072mm | Pass | ||
| ASTM D 6319-06 (Reapproved 2015) | Physical Properties: Tensile strength (Before & After aging) | ≥14MPa | 16.5-19.3 MPa | Pass |
| Physical Properties: Before aging Elongation | ≥500% | 526-560% | Pass | |
| Physical Properties: After aging Elongation | ≥400% | 432-492% | Pass | |
| • 21 CFR 800.20, • ASTM D 6319-06 (Reapproved 2015), • ASTM D5151-19 | Freedom from pinholes: Water leakage test | Inspection Level I, AQL2.5, and Accept/Reject criteria of 10/11. | 2 noncompliance is allowed. | Pass |
| • ASTM D6319-10 (Reappr oved 2015), • ASTM D6124-06 (Reapproved 2017) | 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.