(87 days)
The Nitrile Powder Free patient examination glove is 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.
Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
KIMTECH™ Purple Nitrile™ Examination Gloves, Powder Free, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric acid and Fentanyl in Simulated Gastric acid are single use only, non-sterile, disposable gloves. The powder-free gloves are made of a synthetic copolymer of acrylonitrile and butadiene with a purple color additive. The gloves are available in extra small, medium, large, and extra-large sizes.
This document is a 510(k) Premarket Notification for KIMTECH™ Purple Nitrile™ Powder Free Examination Gloves. It focuses on demonstrating that the proposed device is substantially equivalent to legally marketed predicate devices, particularly concerning its resistance to permeation by chemotherapy drugs, fentanyl citrate, simulated gastric acid, and fentanyl in simulated gastric acid.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the permeation resistance of the gloves are defined by the "Minimum Breakthrough Detection Time" for each substance. For other characteristics, the acceptance criteria are generally "Complies with" or "Pass" based on recognized ASTM and ISO standards.
| Attribute/Test | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Chemotherapy Drugs (Permeation Time) | ASTM D6978-05 (Re-approved 2013): Minimum Breakthrough Detection Time (implied requirement is to demonstrate significant barrier, often >240 min for most drugs but with specific exceptions) | Reported Breakthrough Detection Time (minutes) |
| Blenoxane | >240 | >240 |
| Busulfan | >240 | >240 |
| Carmustine (BiCNU) | (Note: Extremely low permeation time reported) | >3.6 (Warning: Do Not Use With) |
| Cisplatin | >240 | >240 |
| Cyclophosphamide/cytoxan | >240 | >240 |
| Cytarabine | >240 | >240 |
| Dacarbazine (DTIC) | >240 | >240 |
| Daunorubicin | >240 | >240 |
| Docetaxel | >240 | >240 |
| Doxorubicin | >240 | >240 |
| Ellence | >240 | >240 |
| Etoposide/Toposar | >240 | >240 |
| Fludarabine | >240 | >240 |
| Fluorouracil | >240 | >240 |
| Gemcitabine | >240 | >240 |
| Idarubicin | >240 | >240 |
| Ifosfamide | >240 | >240 |
| Irinotecan | >240 | >240 |
| Mechlorethamine HCL | >240 | >240 |
| Melphalan | >240 | >240 |
| Methotrexate | >240 | >240 |
| Mitomycin C | >240 | >240 |
| Mitoxantrone | >240 | >240 |
| Paclitaxel | >240 | >240 |
| Paraplatin | >240 | >240 |
| Rituximab | >240 | >240 |
| Thiotepa | (Note: Extremely low permeation time reported) | >15.9 (Warning: Do Not Use With) |
| Trisenox | >240 | >240 |
| Vincristine Sulfate | >240 | >240 |
| Opioid Fentanyl Citrate (Permeation Time) | ||
| Fentanyl Citrate | >240 | >240 |
| Simulated Gastric Acid (Permeation Time) | ||
| Gastric Acid (simulated) | >240 | >240 |
| Fentanyl in Simulated Gastric Acid (Permeation Time) | ||
| Fentanyl in Gastric Acid | >240 | >240 |
| Dimensions: Overall Length | ASTM D6319 Minimum: 230mm | All sizes comply with length dimensions |
| Dimensions: Width (mean) | ASTM D6319 Minimum: 70 + 10mm (implied range based on standard) | All sizes comply with length dimensions |
| Dimensions: Palm & Finger Thickness | ASTM D6319 Min. Palm: 0.05mm, Finger: 0.05mm | All sizes comply with length dimensions |
| Tensile Strength: Before Aging | ASTM D6319 Min: 14MPa | Complies both before and after accelerated aging |
| Tensile Strength: After Aging | ASTM D6319 Min: 14MPa | Complies both before and after accelerated aging |
| Ultimate Elongation: Before Aging | ASTM D6319 Minimum: 500% | Complies both before and after accelerated aging |
| Ultimate Elongation: After Aging | ASTM D6319 Minimum: 400% | Complies both before and after accelerated aging |
| Freedom from Holes | ASTM D6319 G1, AQL 2.5 (7 Accept, 8 Reject) | Pass |
| Powder-Free | ASTM D6319 Maximum |
§ 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.