(393 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, and Modified-Draize-95 Test, per FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products, 1999". The gloves are made of Nitrile Butadiene Rubber, powder free, ambidextrous (i.e. can be worn on right hand or left hand) with beaded cuff, blue or white colored, single-use disposable devices, that come in five sizes (XS. S. M. L. XL), and supplied in Non-Sterile state. The principle operating characteristic of the device is to prevent contamination between patient and examiner, achieving through conformance of barrier, physical properties and other testing requirements as stated in Section 7.0 of this 510(k) Summary. The gloves are also complied with ASTM D6319-10 and ASTM D5151-11 on water leak test, forming a barrier to prevent contamination between patient and examiner. Testing of the subject device shows it meets the 1.5 AQL for leakage, exceeding ASTM D6319-10 requirement of 2.5 AQL for leakage. The gloves are designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The physical properties of the subject device meet the requirements for tensile strength and elongation (both unaged and aged) in the standard.
I am designed to analyze medical device-related studies and cannot assist with questions about gloves.
§ 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.