5 mil nitrile gloves fda product code database

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Class 2 Device Recall MICROTOUCH(R), NITRILE, Powder Free ...- 5 mil nitrile gloves fda product code database ,Aug 04, 2011·MICRO-TOUCH (R), XL (indicating size extra large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034304, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia. Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.Nitrile Glove Chemical-Compatibility Referencefor a 5-mil or greater thickness glove. If gloves come in contact with the chemical below, they must be changed immediately*to avoid exposure. *Breakthrough mayoccur in under one minute for a 5-mil or lesser thickness glove. *See the FACT SHEET: Hydrofluoric Acidin the Chemical Hygiene Plan for glove recommendations for HF.



Critical Response Nitrile Exam Gloves • Foreman Safety ...

Critical Response Nitrile Exam Gloves Critical Response nitrile exam gloves are specifically made for demanding, high-stress situations Strong, highly visible gloves provide advanced protection and optimal grip ideal for rapid response Resist permeation of fentanyl for up to 240 minutes (permeation testing per ASTM D6978-05) Exceeds FDA testing requirements for pinhole deficiencies with an AQL ...

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 …

510(k) Premarket Notification - Food and Drug Administration

Jun 28, 2021·510 (k) Premarket Notification. A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513 (i) (1) (A) FD&C Act) that is not subject to premarket approval.

Ansell 92-500 $30.33 Disposable Nitrile Gloves with ...

Disposable Gloves, Acceptable Quality Level (AQL) 4.0, Brand and Series Ansell TouchNTuff 92-500, Disposable Glove Type Food Contact, General Purpose, Double Gloving Method Inner, Glove Materials Nitrile, Grain, Nominal Palm Thickness 5 mil, Latex-Free Yes, Silicone-Free Yes, Glove …

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

KleenGuard™ G10 Blue Nitrile Gloves (57371), Small (Sml ...

KleenGuard™ Personal Protective Equipment (PPE) enables rather than inhibits – allowing for maximum productivity and safety for you and your employees. Your employees are your most valuable asset, and KleenGuard™ G10 Blue Nitrile Gloves help keep them safe. These top-selling protective gloves are resistant to oils and splashes, making them a great choice to help protect your team.

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.

November 15, 2018 Shanghai Truthful Information Technology ...

5.0 . Indication for Use The Nitrile Glove Powder Free Black is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. 6.0 . Device description The proposed device is Powder Free Nitrile Examination Gloves…

NitroMax Powder-Free Nitrile Exam Gloves | Emerald Gloves

NitroMax Powder-Free Nitrile Exam Gloves – 5 Mil. Made with 100% nitrile to alleviate the potential for adverse reactions associated with latex protein, NitroMax still provides the protection, comfort, fit, and sensitivity of a latex glove. This product utilizes soft and durable nitrile …

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.

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.

Nitrile Glove Chemical-Compatibility Reference

for a 5-mil or greater thickness glove. If gloves come in contact with the chemical below, they must be changed immediately*to avoid exposure. *Breakthrough mayoccur in under one minute for a 5-mil or lesser thickness glove. *See the FACT SHEET: Hydrofluoric Acidin the Chemical Hygiene Plan for glove recommendations for HF.

Do Your Gloves Comply with FDA Recommendations and ...

Jun 01, 2017·Food contact gloves are certified under FDA Title 21 CFR Part 177, which states that the components of the glove comply with the FDA regulations and the gloves consist of “Substances generally recognized as safe for use in food or food packaging.”. However, the quality and safety of disposable gloves is limited to Letters of Compliance and ...

Medical Gloves for Sale | Medical Gloves in Bulk | PalmFlex

Medical gloves, also known as exam gloves, meet the inspection standards of the FDA and ASTM to ensure utmost security for medical professionals exposed to hazardous materials. Our disposable medical gloves for sale are powder free and come in latex, nitrile, and vinyl. They protect everyone from general practitioners and nurses to dentists and lab technicians against biohazards and ...

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 Rubber Gloves | Latex Free Exam Gloves ...

Product Description. SkinTX Cool Blue® exam glove is our most economical all purpose nitrile exam glove. New nitrile formulation allows for thin wall construction and exceptional tactile sensitivity. Manufactured to ISO 9001 standards. Engineered to safeguard workers who come in contact with chemotherapy agents (ASTM D6978), bodily fluids and ...

SemperCare 4.5mil Latex Powder Free Exam Grade Gloves ...

100 Gloves/Box. Sizes XS-XL. Caution: This product contains natural rubber latex which may cause allergic reactions. Safe use of this product by or on latex sensitized individuals has not been established. Product Reviews. (10 Boxes/1000 Gloves) SemperCare 4.5mil Latex Powder Free Exam Grade Gloves…

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 ...

MICRO-TOUCH® Nitrile Sterile - Ansell

Nitrile, sterile pair packed, powder-free examination glove featuring extended cuff. Key Features and Benefits. Packed as a pair of gloves per pack. 12” extended cuff for additional protection. Gamma sterilized minimum 25kGy to provide sterility. Tested for use with chemotherapy drugs*. show more.

Disposable Gloves for Sale | Bulk Nitrile, Vinyl & TPE Gloves

With thicknesses up to 3 mil for food service and 6 mil for industrial use, they can withstand many harsh applications while offering decent tactile sensitivity. ... A medical facility that uses latex, vinyl and nitrile gloves might use color to distinguish between the three. A hospital could also color-code within a single glove type. For ...

HIGH FIVE® Nitrile Disposable Powder-free Glove, Blue ...

These High Five Products Nitrile Disposable Powder Free Gloves are manufactured using a soft and stretchy formulation that offers excellent durability as well as comfort. Textured for enhanced gripping power. Features: Powder free; Latex-Free; 9 1/2" length; Thickness + or - 0.01: 4.0 mil (palm), 4.0 mil (finger), 3.5 mil (cuff) Medical/Exam ...

(10 Case/1000 Gloves) Pro-Guard® Blue Nitrile Disposable ...

These gloves meet FDA standards for food handling. ... Complies with Federal regulations for food contact; Product Reviews . Related Items (10 boxes/ 1000 Gloves) Vinyl Disposable Powder Free Industrial/Foodservice Gloves. Regular price $100.00 Out of Stock (10 Boxes/1000 Gloves) SemperForce 5 mil Black Nitrile Powder Free Exam Gloves. Regular ...

Nitril Gloves

Trade/Device Name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class l, reserved Product Code: LZA, l.zc, QDO Dated: February 27, 2020 Received: March 5, 2020

Product Code Classification Database | FDA

This database contains device names and their associated product codes. The name and product code identify the generic category of a device for FDA. The Product Code assigned to a …