4 days ago · Product Classification FDA Home Medical Devices Databases Safety Zone Safety Zone Powder Free Blue Nitrile Gloves - X-Large Size - Silicone-free, Latex-free - 9. It's a great fit for janitorial, tattoo, beauty salon, gardening use, automotive detailing, light household work, food service, and cleaning. Feb 21, 2024 · This specification covers certain requirements for nitrile rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. CAUTION: COMPONENTS USED IN GLOVE MANUFACTURING MAY CAUSE ALLERGIC REACTIONS IN SOME USERS. Tacky finish Fingertip thickness is 0. Best prices, bulk discounts, trusted deals at go4WorldBusiness. This is a single-use, powder-free, non-sterile device. New Search | Submit an Adverse Event Report Brand NameRESTORE SENSE Common Device NameDBD-GLOVE,EXAM,NITRILE,RESTORE,OAT SENSE Manufacturer (Section D) MEDLINE INDUSTRIES, LP three lakes drive northfield IL 60093 Manufacturer Contact danielle tognocchi three lakes drive northfield, IL 60093 MDR Report Key23822613 Report Number1417592-2025-00718 Device Sequence Number8661607 Product Code LZA Nitrile Gloves are the perfect compromise between latex and vinyl. Compliant with FDA foodservice regulations. They are FDA-approved with a low dermatitis potential claim and are accelerator-free, helping reduce the risk of both Type I and Type IV allergic reactions. Designed to allow easy double gloving Gloves are packed in sterile pairs; inner wrapper is ozone resistant multi-vac packaging. [15] In carbon tetrachloride Shadow 6 mil black nitrile gloves with superior tear resistance, textured grip, and medical-grade protection. Nitrile is made from an allergy-safe compound that feels a lot like latex, but it's much stronger and more comfortable to wear. . Illustrative is the complex dichlorotetrakis (dimethyl sulfoxide)ruthenium (II) (RuCl2(dmso)4). 20 mm (8 mil) Large size gloves have an extended cuff for extra protection. These gloves will change everything you thought you knew about 3-mil nitrile. com. 5C Nitrile Exam Gloves Tested for use with Chemotherapy Drugs using ASTM D6978-05. Gloves used for protection against chemotherapy drug exposure must be selected specifically for the type of glove being used. 5C Nitrile Exam Gloves Violet Blue Tucker Nitrile Gloves, Green, Large, Unsupported Y8323L Knit-Lined All Purpose Hand Protection Designed For Use Around Steam Tables Hot Holding Equipment Fryers Dish Machines Or When Using Cleaning Chemicals. In general, the oxygen-bonded mode is more common. In addition to their use in clinical or healthcare environments, examination gloves are also worn to protect the hands in quality control laboratories, manufacturing plants and R&D laboratories. Nitrile is made from an allergy-safe compound that feels a lot like latex, but it’s much stronger and is more comfortable to wear. 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 Reviews Q&A About this product Size 11 flock lined nitrile gloves has high performance nitrile compound which provides an outstanding combination of chemical resistance and strength. All gloves, apart from medical/exam type disposables are referenced in 21 CFR Parts 174 & 177 when used in food handling applications. Medical Glove Guidance Manual This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. Free next-day delivery when you spend $35+. Complies with FDA food handling requirements 21 CFR, Part 177. Get Ammex Professional Series Powder Free Nitrile Exam Gloves, Latex Free, XS, Blue, 100 Gloves/Box (APFN40100) fast at Staples. Oct 20, 2025 · Search by the manufacturer name, product code (e. Related to its ability to dissolve many salts, DMSO is a common ligand in coordination chemistry. Kimtech™ Sterling™ Nitrile Gloves guard against contamination by chemical splash and micro-organism hazards, delivering seamless protection when and where it counts. A-VANGUARD GLOVES AVANG-N-S GUDID 00628032800018 Domrex Pharma Inc FDA. It complies with FDA CFR Title 21 Indirect Food Additive Regulations Part 177 for safe food handling applications. Confirm Manufacturer Claims: A legitimate manufacturer can provide documentation or a letter of guarantee verifying their compliance with FDA regulations. FDA regulate latex and nitrile gloves (examination and surgical) as medical devices. report › GUDID › Domrex Pharma Inc › 00628032800018 The Product Classification Database contains medical device names and associated information developed by CDRH in support of its mission. This product complies with FDA 21CFR177 as safe for food contact. Textured fingertips provide excellent tactile sensitivity and dexterity Improved conformability provides superior fit and extended wear comfort Reduces Bound Tree is a national distributor of prehospital emergency medical supplies, equipment, and pharmaceuticals for EMS care providers.

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