sterile nitrile gloves blue 510k form pdf

High Elasticity:
Stretch Resistance

Thick Design:
Puncture Resistant

Sealed &Waterproof:
Care for Your Hands

Latex and allergy free:

These gloves have latex free materials that are useful for those people who have allergy to the latex. 

Puncture resistant:

Nitrile gloves are specifically manufactured in a puncture-proof technology. 

Full-proof sensitivity:

These are produced to fulfill sensitivity requirements.

NITRILE GLOVE ORDER FORM - cdaonline.org- sterile nitrile gloves blue 510k form pdf ,Eective Prices subect to change PRM M GLOVES & SUPPLIES NITRILE #/Box $/100 XS S M L XL XXL Case price TOTAL Ansell Micro-Touch Denta-Glove, textured, blue 100/box $6.37 N/A $63.75 Ansell Micro-Touch, textured 200/box $6.95 N/A $139.00 BeeSure Nitrile, textured, blue 100/box $6.82 N/A $68.25 BeeSure Glacier, textured, glacier blue 300/box $4.67 N/A N/A $140.25HIGH-QUALITY N ITRILE O P WDER FREE GLOVESEU standard, ISO13485, CE, USFDA, 510K Certificate, EU 2016/425, CE, FDA, 510K Certificate and Quality Standard: EN455-1, EN455-2, EN455-3, EN455-4 Thailand Acrylonitrile butadiene synthetic Nitrile Powder-free with one side of the glove chlorinated to allow good dry-hand donning. Blue. Ambidextrous, beaded cuff with finger- textured finishing



Kimberly-Clark™ Purple Nitrile™ Exam Gloves (55082), 5.9 ...

Your valuable employees deserve the worry-free protection of Kimberly-Clark Purple Nitrile Exam Gloves. These purple nitrile gloves guard against incidental splashes, are made of a highly durable nitrile polymer and are powder free and not made with natural rubber latex (some say “latex free”). The gloves are a 9.5” long, are ambidextrous and have a beaded cuff for easy donning.

510K Summary - Food and Drug Administration

NITRILE Powder-Free Exam Glove is substantially equivalent to the predicate K08 1260, KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves, and to predicate K992830, Safeskin Polymer-Coated Nitrile Examination Gloves, Traditional 510(k) Notification: KIMBERLY-CLARK* LAVENDER Section 3 - 510OK Summary Page 3 of 3

Medical and protective gloves - Mercator

mCare | powder-free nitrile blue examination gloves zl Length (mm): 240 mm Colour: blue Feature: non sterile, ambidextrous, beaded cuff Surface: palm textured/finger textured Packing: 100 pcs/10×100 pcs Standards: ASTM D6319, EN 455, EN ISO 374, ISO 13485, ISO 9001 mCare | powder-free nitrile examination gloves zN Length (mm): 240 mm Colour: cobalt blue Feature: non sterile, ambidextrous ...

Gloves - Cardinal Health

In addition, all of our glove offerings are produced with the same standards of quality and service that customers have come to rely on from Cardinal Health. Surgical gloves As a leader in the industry, with over 50 years of surgical glove experience, Cardinal Health continually enhances our surgical glove portfolio to provide protection ...

:: Our Certificates : Producer of Latex Glove ,Natural ...

SGS ISO 13485 Medical devices. Meeting the Requirements 13485:2016 EN 13485:2016. For the Activities Manufacture of Non-Sterile Powdered & Powder Free Natural Rubber Latex Examination Gloves. Valid From 25 December 2019. Preview PDF file.

NITRILE GLOVE ORDER FORM

Eective Prices subect to change PRM M GLOVES & SUPPLIES NITRILE #/Box $/100 XS S M L XL XXL Case price TOTAL Ansell Micro-Touch Denta-Glove, textured, blue 100/box $6.37 N/A $63.75 Ansell Micro-Touch, textured 200/box $6.95 N/A $139.00 BeeSure Nitrile, textured, blue 100/box $6.82 N/A $68.25 BeeSure Glacier, textured, glacier blue 300/box $4.67 N/A N/A $140.25

Examination & Specialty Gloves

STERILE NITRILE. Tronex disposable sterile nitrile powder-free exam gloves provide exceptional barrier . infectious substances, offering legendary Tronex comfort, performance, and quality. Sterilized to all ASTM and ISO requirements with FDA 510(k) approval, Tronex sterile nitrile gloves …

Nitrile Gloves - mecmedicare.cn

A disposable Nitrile examination glove. A great alternative to latex gloves, latex-free nitrile gloves offer quality resistance to chemicals and have a form-fitting design to prevent gloves from falling off while in use. Available in different colors, to prevent confusion in the workplace. - Textured Fingertip - Powder free - No Natural Latex

FLEXAL™ Nitrile Medical Gloves | Cardinal Health

Footnotes and references: *GHX/ HPIS D_MAT2015 1 Caution: Gloves used for protection against chemotherapy drug and laboratory chemical exposure should be selected specifically for the type of chemicals being used. 2 This Cardinal Health product helps healthcare facilities comply with the USP <800> standard for the safe handling of hazardous drugs.. Note: Review Safety Data Sheets (SDS) …

Product Information

510(k) Number (ifknown) Kl7l 22 Device Name Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color Indications for Use (Describe) The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is

Examination & Specialty Gloves

STERILE NITRILE. Tronex disposable sterile nitrile powder-free exam gloves provide exceptional barrier . infectious substances, offering legendary Tronex comfort, performance, and quality. Sterilized to all ASTM and ISO requirements with FDA 510(k) approval, Tronex sterile nitrile gloves …

Kimberly-Clark™ Sterling™ Nitrile Exam Gloves (50707), 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 ...

Kimberly-Clark™ Sterling™ Nitrile Exam Gloves (50707), 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 ...

BLUE NITRILE Exam Glove | Halyard Health

Halyard Health BLUE NITRILE* Exam Gloves deliver exceptional protection for moderate to high exposure to fluids or chemicals. Blue textured fingertips enhance instrument control in both wet and dry situations. A powder-free and natural rubber latex-free design reduces potential allergic reactions and minimizes the drying effects of glove powder ...

Gloves - Marketingshop DK

Examination Gloves Nitrile Nitrile, textured, powder free Size Colour Units per Article no. Width Length pack/cll 290417 X-small 76 mm 240 mm Blue 150/1500 Nitrile, textured, powder free Size Colour Units per Article no. Width Length pack/cll 290437 X-small 75 mm 240 mm Black 200/2000 Nitrile, textured, powder free Size Colour Units per

510K Summary - Food and Drug Administration

510(k) Number (if known): K093516 Device Name: NitriTech® Non-Sterile Powdered Nitrile Medical Examination Gloves in the color blue. Indications For Use: The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the

Gloves - Cardinal Health

In addition, all of our glove offerings are produced with the same standards of quality and service that customers have come to rely on from Cardinal Health. Surgical gloves As a leader in the industry, with over 50 years of surgical glove experience, Cardinal Health continually enhances our surgical glove portfolio to provide protection ...

Examination & Specialty Gloves - Amrita Supply

9250-05 XS 100 gloves/box, 10 boxes/case Blue 9250-10 SM 9250-20 MD 9250-30 LG 9250-35 XL 9250-40 2XL ... FDA 510(k) approval, Tronex sterile nitrile gloves are packaged conveniently in ... -Free Exam Gloves Form-fitting, powder-free choice with comfortable and smooth satin finish, ...

Gloves - Cardinal Health

In addition, all of our glove offerings are produced with the same standards of quality and service that customers have come to rely on from Cardinal Health. Surgical gloves As a leader in the industry, with over 50 years of surgical glove experience, Cardinal Health continually enhances our surgical glove portfolio to provide protection ...

Disposable Nitrile Exam Gloves by Szemi-Trade Kft ...

Nitrile Powder-free Disposable Non-sterile Exam Gloves Shark Gloves Brand. Made in Thailand. - High tensile strength for more durability and reliability - More resistant to chemicals and pathogens than natural latex rubber - Ambidextrous with straight fingers for ease of use and comfort - Fully textured grip for superior performance even when wet - Polymer coated for easy donning - Beaded cuff ...

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.

Blue Nitrile Medical Examination Gloves

Blue Nitrile Medical Examination Gloves Order Code 6390 Available Sizes S/M/L Materials & Construction ... 510(k) TGA APPROVED. qube Powder Free Nitrile Examination Gloves Ambidextercus Textured Surface .Beaded Cuff. Puncture Resistant. Non Sterile NITRILE POWDER FREE 100 GLOVES .

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.

Nitrile Gloves - mecmedicare.cn

A disposable Nitrile examination glove. A great alternative to latex gloves, latex-free nitrile gloves offer quality resistance to chemicals and have a form-fitting design to prevent gloves from falling off while in use. Available in different colors, to prevent confusion in the workplace. - Textured Fingertip - Powder free - No Natural Latex