5 mil nitrile gloves fda product code database

Product Codes and Product Code Builder | FDA

May 12, 2021·Industry Code: This element is two numbers from "02" to "98.” An industry code determines the broadest area into which a product falls. Some examples are dental for all …

Appendix III. 510(k) Summary - Food and Drug Administration

Feb 19, 2008·3). NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) K Number: K063 046 Product Code: LZA Intended Use: The nitrile examination gloves is a disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Manufactured by Hartalega SDN BHD 4). POWDER NITRILE ...

U.S. International Trade Commission - HTS Tool

Welcome to the Harmonized Tariff Schedule reference tool. This site provides a chapter-by-chapter version of the HTS.

Ammex Large, 1000/case, 5 Mil - Gloveworks Blue Nitrile ...

May 15, 2017·AMMEX Gloveworks Blue Nitrile Powder Free Industrial Gloves are 5 mil thick in the palm with 6-mil fingertips, so they’re made for working with tools and machinery. Barrier protection is excellent against a long list of common chemicals and specialty chemicals. The grip is solid—thanks to a micro-roughened surface and textured fingertips ...

Important regulatory considerations for the supply of ...

An appropriate type of glove is selected within the context of the setting and needs of health care professionals and patients. Medical gloves may be made of latex, vinyl, synthetic polymer, or nitrile. They may also be sterile or non-sterile. For example, disposable, non-sterile, nitrile or vinyl gloves in first aid kits are medical gloves.

Nitrile Work Gloves | LabSource, Inc.

Nitrile gloves are an ideal alternative to latex, and LabSource offers one of the widest selections of nitrile gloves on the web. Whether you’re in search of thin industrial nitrile gloves,nitrile chemical-resistant gloves, disposable nitrile glovesor those made for a variety of other uses, you can find them all right here at LabSource.

Standard Specification for Nitrile Examination Gloves for ...

1. Scope. 1.1 This specification covers certain requirements for nitrile rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. 1.2 This specification covers nitrile rubber examination gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile or nonsterile or ...

Search the Releasable 510(k) Database | FDA

You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following format:

Nitrile Powder-Free Examination Gloves

Nitrile Powder-Free Examination Gloves NON-STERILE Along with the durability and strength of nitrile, these gloves were tested using ASTM standards for permeation against 65 chemotherapy drugs and chemicals* Their ambidextrous design with textured fingertips and beaded cuff ensure a sturdy, . comfortable product, combining safety and tactile sensitivity.

FrontLine™ Nitrile Gloves | Life-Assist

FrontLine nitrile exam gloves are designed for reliable protection in higher risk situations. These gloves are tested to protect against fentanyl and other inadvertent contact with synthetic opiates. Advanced non-latex nitrile polymer offers superior stretch and comfort Fully textured surface for im

Product Classification - Food and Drug Administration

Jul 12, 2021·5-62 ANSI ASQ Z1.4-2003 (R2018) Sampling Procedures and Tables for Inspection by Attributes; 6-147 ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs; 6-178 ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves

N300 Series Nitrile Exam Gloves - AED Superstore

N300 Series Nitrile Exam Gloves Spec Information DIMENSIONS Item# Size Palm Width (mm) Length ... N300L Large 105 ± 5 240mm / 9.5 inches N300XL Extra-Large 115 ± 5 240mm / 9.5 inches. U.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.04.08 Silver Spring, MD 20993 ... Product Code: LZA, LZC Dated: September 19, 2019

fda white list for medical gloves for sale

FDA Registration of Latex and Nitrile gloves - fdahelp.us. FDA regulate latex and nitrile gloves (examination and surgical) as medical devices. Even though the gloves are class 1 device, it requires FDA 510K Clearance, Medical device establishment registration and device listing to market in the USA.Powdered gloves are not allowed to market in the USA for medical purpose.

WAXIE Shield Nitrile Black Medium Powder Free General ...

Powder free, disposable, general purpose nitrile black medium gloves with a rolled cuff. Ambidextrous glove has textured finger tips and is FDA compliant. Applications: cleaning, small parts handling and a variety of other tasks. 4-5 mil thick. Non-powdered gloves are usually treated with chlorine wash and/or polymer coating processes.