nitrile gloves 510k pdf template download

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Disposable Nitrile Gloves – Kori Medical- nitrile gloves 510k pdf template download ,KoriMed™ Nitrile Powder-Free Examination Gloves are 510k approved for Medical Use and exceeds ASTM D6319 Specification for Bitrile Examination Gloves for Medical Application, meets and exceeds ASTM D6978 Resistance of Medical Gloves to Permeation by chemotherapy Drugs and manufactured and tested under ISO 9001 and ISO 13485 for Quality Management Systems for Medical Devices.Kimberly-Clark Purple Nitrile Exam Gloves Datasheetdeserve the worry-free protection of Kimberly-Clark * Purple Nitrile Exam Gloves. Our gloves guard against incidental splash exposure. The gloves are made of a highly durable nitrile polymer that eliminates the risks and costs associated with type 1 natural rubber latex allergies.

Medical device application forms - Canadaa

Jun 10, 2016·Application forms listed below must accompany medical device applications filed by a manufacturer or sponsor. Medical device problem report form for health care professionals [2019-06-26] Application Form for New Investigational Testing Authorization (ITA) (PDF …


Gloves Black Nitrile Gloves • Black color hides stains during food prep, janitorial work and light industrial use • Offers the BEST hand protection over latex, vinyl and synthetic gloves • Can be worn for extended periods of time • Highly resistant to animal fats and many chemicals • Puncture-resistant DON# Size Qty 1060697 Small 1m/cs

Medical Devices Active Licence Listing (MDALL) - Canadaa

MDALL online query. MDALL online query is an HTML application used to search the MDALL. A search can be done by Company Name, Company ID, Licence Name, Licence Number, Device Name, Device Identifier. Device Identifier is a unique series of letters or numbers or a combination of both, assigned by the manufacturer to identify the device.

ABENA Glove Range

High-quality, fit-for the purpose gloves are vital to ensuring a safe and hygienic environment for patients, staff and visitors. By choosing an Abena glove, you gain access to more than 30 years of experience in the glove and healthcare industry. Our gloves experts are ready to help you find the right solution for the right purpose, advising on ...

Downloadable 510(k) Files | FDA

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NITRILE GLOVES – SolisDisplay®

ANSELL EDGE 82-133 - INDUSTRIAL GLOVES, DISPOSABLE, POWDER-FREE NITRILE GLOVES Manufactured with a thinner nitrile formulation that increases comfort and improves flexibility without compromising protection.Offers textured fingertips to provide an improved grip for a variety of applications.Packed 300 gloves per dispenser box to provide additional value and convenience …

Nitrile Gloves - Brighton-Best

May 31, 2011·1. 1 Type Nitrile Examination Glove, Powderfree, Non-sterile 1. 2 Material 100% Synthetic Nitrile Latex 1. 3 Color ( Pigment ) o Off white o Blue o Black 1. 4 Design and Feature Ambidextrous, textured, beaded cuff 1. 5 Powder No powder lubricant added 1. 6 Storage Condition The gloves shall maintain their properties when stored in a dry condition.

醫療器材美國FDA 510k -

• 若需要510(k)或PMA,產品列名只能在獲得SE letter或PMA核准之後 才能列名。假如該產品是唯一列名的產品,需在獲得510(k)/PMA再 進行廠商註冊。 • 列名的醫療器材並不代企業或器材被FDA批准 • 如果510(k)或PMA的批准函上有多個産品編碼,需要在每個産品編碼 下 ...

510K Nitrile Gloves - Renyi Castings

May 14, 2020·510K Nitrile Gloves Renyi Castings. This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish.

Small Lots – The Glove Report

May 25, 2021·Durable Nitrile Gloves 690K $6.50 all in (100 Count) Brand is named Durable 4 MIL POWDER-FREE GLOVES 690,000 Boxes — 3 locations $6.50 per box includes $1.00 commissions and shipping costs to destination. 􀁩 Industrial grade blue nitrile 􀁩 Powder-free 􀁩 4 mil 􀁩 100 gloves per box 􀁩 Non-sterile 􀁩 Single use 􀁩 Rolled cuff 􀁩 FDA Cleared 􀁩 510(k) 􀁩 ASTM D6319

Tests required for latex and nitrile gloves for FDA 510K ...

US FDA Medical Device Labeling Requirements - Gloves. Contents of examination and surgical gloves (Latex / Nitrile) 510k Notification. US FDA 510K Submission Format. FDA publish all 510k clearance on fda website, you can find substantial equivalence letter at Below are examples of examination and surgical glove 510k clearance letter

Nitrile NBR powder free medical gloves, Vietnam made ...

Detailed info about Nitrile NBR powder free medical gloves, Vietnam made. Contact Taiwan Medical Glove supplier-PROS CORPORATION for gloves, medical gloves, en, nitrile gloves, ce, fda, NBR, 510K, ASTM, powder free, ISO on Taiwantrade.

template for 510k submission device description Medical ...

How to create a template for 510k submission device description Posted by Rob Packard on November 4, 2015. This article explains how to create a template for a 510k submission device description (i.e., Section 11). The template addresses each of the requirements of a device description in the FDA refusal to accept (RTA) guidance document.

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MICRO-TOUCH® Nitrile EP™ - Ansell

Description. This non-sterile glove has an extended cuff provides extra protection when healthcare providers are exposed to chemotherapy agents, bodily fluids or blood-borne pathogens in high-risk clinical settings. It provides excellent chemical and puncture resistance and is textured for better grip in wet and dry procedures.

Gloves - LifeScience Inc.

Guardian Nitrile medical grade gloves are powder-free, textured, and are 5 mil thick. Guardian nitrile medical grade gloves are available with a 12 inch cuff. These 510K certified medical grade nitrile gloves are supplied 100 per box, 10 boxes per case

Kimberly-Clark™ Sterling™ Nitrile Exam Gloves (50708), 3.5 ...

Kimberly-Clark Sterling Nitrile Exam Gloves are low-cost nitrile glove combining the sensitivity of latex with the protection and strength of nitrile. The innovative gloves’ manufacturing technology delivers a comfortable and affordable glove with the protection and cleanliness you need. The thin mil gray gloves (3.5 mil) are ambidextrous, powder-free, have an AQL of 1.5, and feature beaded ...

General Features and Specifications of Nitrile Gloves, by ...

All gloves deteriorate over time and nitrile gloves are no exception. If you are confused about whether to order powdered or powder-free nitrile gloves, allow us to suggest that you try powder-free nitrile gloves first. Nitrile rubber is not as "sticky" as latex and many people do not have any trouble getting their nitrile gloves on and off.

Standard Specification for Nitrile Examination Gloves for ...

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 bulk non-

510(k) Premarket Notification

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.


GLOVES & SUPPLIES NITRILE #/Box $/100 XS S M L XL XXL Case price TOTAL Ambitex Nitrile, textured, royal blue 100/box $4.45 N/A $44.50 Ansell Micro-Touch Denta-Glove, textured, blue 100/box $6.50 N/A $65.00 Ansell Micro-Touch, textured 200/box $7.00 N/A $140.00 BeeSure Nitrile, textured, blue 100/box $7.05 N/A $70.50 BeeSure Glacier, textured, glacier blue BUY 9 BOXES GET 1 BOX …

Paloma Specs Sheet (Singapore) R3

chemical expected of a nitrile glove. You owe it to yourself to try this exceptional nitrile glove from GloveOn. FEATURES ... 100 gloves per box 10 boxes per carton REGULATORY COMPLIANCE FDA 510(k), MDD 93/42/EEC, REACH, ROHS Directive 2002/95/EC, EC 10/2011, EC 1935/2004 STANDARDS ASTM D6319, ASTM D412, ASTM D573, ASTM D5151, ASTM D6124, EN455 ...

510(k) Premarket Notification

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.

FLEXAL™ Nitrile Medical Gloves | Cardinal Health

FLEXAL™ Nitrile Medical Gloves are the best-selling exam gloves in our High Use portfolio. They provide tactile sensitivity and protect hands from potentially infectious materials.*. CUSTOMER SERVICE. For product specifications and service, please call our Customer Service team. Call Customer Service 800.964.5227.