(102 days)
The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are 245mm in length and dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.
The provided document describes the safety and performance testing of KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves. However, this is a 510(k) premarket notification for a medical glove, not an AI/ML medical device. Therefore, the information required to answer the specific questions about acceptance criteria for an AI/ML device, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, or clinical study design (MRMC), is not present in this document.
The document focuses on non-clinical performance tests of the physical and chemical properties of the gloves.
Here's an attempt to extract relevant "acceptance criteria" and "reported performance" based on the provided document, framed as close as possible to the request, while highlighting the limitations for an AI/ML context.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is for a physical medical device (gloves), the "acceptance criteria" are defined by recognized standards (e.g., ASTM, ISO) for physical properties, chemical resistance, and biocompatibility.
| Test Category | Acceptance Criteria (from Standards) | Reported Device Performance (KIMTECH™ Polaris™ Nitrile Gloves) |
|---|---|---|
| Dimensions | Length: ≥ 230 mm | |
| Width (mean): ≥ 70 mm | ||
| Finger/Palm Thickness: ≥ 0.05 mm | Meets requirements (All sizes comply with length, width, and thickness dimensions) | |
| Physical Properties | Before Aging: | |
| Tensile Strength: ≥ 14 MPa | ||
| Ultimate Elongation: ≥ 500% | ||
| After Aging: | ||
| Tensile Strength: ≥ 14 MPa | ||
| Ultimate Elongation: ≥ 400% | Meets requirements (Complies both before and after accelerated aging) | |
| Freedom from Pinholes | ASTM D6319 G1, AQL 2.5 (7 Accept, 8 Reject) | |
| No leakage | Pass (AQL 0.65) - Note: Subject glove AQL is tighter than the standard, indicating better performance. | |
| Powder-Free | ≤ 2 mg / glove | Passed at |
§ 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.