(20 days)
These Powder Free, Nitrile Examination Gloves are a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
US Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are Blue, Polymer coated, Nonsterile, Powder Free, Ambidextrous Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs. These are made up of 100% synthetic Nitrile Butadiene Latex. Its surface finish is finger textured with beaded cuff.
The provided text describes the acceptance criteria and performance data for Memorial™ Gloves, which are Powder Free, Nitrile Examination Gloves. The submission is a 510(k) premarket notification to the FDA, indicating a claim of substantial equivalence to already marketed predicate devices.
Here's an analysis of the provided information, framed by your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents several tables summarizing non-clinical tests. I will consolidate the key information from pages 15-17.
| Testing/Standards (Parameter) | Purpose of the Test | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Physical Properties | |||
| ASTM D-3767 (Dimensions: Length, Width, Thickness) | To determine the length, width and thickness of the gloves | US Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) should meet the requirements of ASTM D6319. | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Specific values: Length Min 230mm, Width S 80, M 95, L 110, XL 120, Thickness (Cuff: 0.05 ± 0.02, Palm: 0.07 ± 0.02, Finger: 0.09 ± 0.02)) |
| ASTM D-412/D-573 (Tensile Strength & Elongation) | To determine the Tensile strength and elongation in gloves before aging and after aging | Before aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 500%min. After aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 400%min. | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Specific values are stated to meet these criteria, consistent with the acceptance criteria.) |
| ASTM D-5151 (Leakage/Detection of Holes) | Testing for freedom from holes as per ASTM D-5151. | The gloves should be free of holes (Meets with the requirement of ASTM D 5151, following ASTM D 6319 AQL 2.5/Inspection Level G-I). | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Stated as meeting ASTM D 5151, following ASTM D 6319 AQL 2.5/Inspection Level G-I) |
| ASTM D6124 (Powder Content) | To Determine the powder residue using Test Method D6124. | 2.0 mg Maximum | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Specific value stated as Max 1.38 mg/glove, which is |
§ 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.