sterile nitrile gloves blue 510k form 100s

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public …- sterile nitrile gloves blue 510k form 100s ,Blue Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made ...Jiangsu Huayuan Medical Technology Co.,Ltd. Disposable ...Device Name: Powder Free Nitrite Patient Examination Gloves, Blue Color Company name: Jiangsu Dongling Plastic & Rubber Co., Ltd. 510(K) Number: KI 10247 4.0 Device Description: 4.1 How the device functiont: Nitrile films form a barie to body fluids and bloodborne Pathogens 4.2 Scientific concepts that form the basis for the device



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 ...

Light Blue Nitrile Exam Gloves - Box/100 - USA Scientific, Inc

Fully textured for exceptional wet grip and sensitivity. Light blue color. Ambidextrous, 9.5" long with beaded cuff. Passes viral penetration tests. Powder-free, light blue nitrile gloves are an excellent alternative to latex. Soft and supple, they are easy to don and offer unequaled fit and feel compared to conventional exam gloves.

July 2017 510(k) Clearances | FDA

510(k) summaries or 510(k) statements for final decisions rendered during the period july 2017 ... nitrile examination gloves, blue ug global resources sdn. bhd. 510(k) no: ... sterile nitrile ...

New VGLOVE / Skymed Nitrile Gloves Examination Gloves For ...

Aug 11, 2020·New VGLOVE / Skymed Nitrile Gloves Examination Gloves For Sale - DOTmed Listing #3262543: Nitrile Gloves, Powder-free, Blue 4mm ,FDA Blue color, 100 single gloves in a Box, 10 boxes in a carton ...

Large Thick Blue Nitrile Exam Gloves (100 Gloves/Box)

Safety Zone Blue Nitrile Exam Gloves are great general use work gloves. They are form-fitting and durable, terrific for painting, cleaning, pet care, auto care, and a wide range of other uses. Safety Zone gloves are trusted across multiple industries nationwide.

Blue Nitrile Gloves - Powder-Free Medical Exam Gloves ...

Blue/Purple Nitrile Exam Gloves - Medical Grade, Disposable, Powder Free, Latex Rubber Free, Heavy Duty, Textured, Medical, Food Safe. Available in Small, Medium, and Large Sizes. Prices are based on number of boxes. Price per box of 100 gloves per box. Quantity in 1 Box - 100 Gloves …

Gloves Class 100 at Thomas Scientific

TechNiGlove International. TN2000 Series Class 100 (12") Low Particle Nitrile Gloves for Controlled Environments TechNiGlove 12" ambidextrous Class 100 nitrile gloves are available in both White and Blue. Microtextured Fingertips provide excellent grip on all surfaces. 100% nitrile gloves contain no natural rubber….

Blue Nitrile Glove – E Glove

Type : Powdered & Powder-Free, Non-sterile. Material : 100% Synthetic Nitrile. Colour : Blue, White & Black. Design & Features : Powdered: Ambidextrous, finger textured pr palm textured surface, beaded cuff, USP grade absorbable cornstarch. Powder-Free: Polymer coated or online single chlorinated, offline double chlorinated, ambidextrous ...

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 Examination Gloves 510K In Stock — Peach Medical Sourcing

Gloves are available by the case only (10 boxes per case). Material: Nitrile (100% Latex-Free) Type: Non-Sterile. Glove Design & Feature: Ambidextrous and Fully Textured. Usage: For Single Use Only. Color: Blue. ASTM 6319. Thickness: 4.0 mil. Packaging: 100 pieces per box / 10 boxes per case. Automated packing to enhance single glove dispensing

Medium Thick Blue Nitrile Exam Gloves (100 Gloves/Box)

Product Overview. Safety Zone Blue Nitrile Gloves are great general use work gloves. They are form-fitting and durable, terrific for painting, pet care, auto care and a wide range of other uses. Safety Zone gloves are trusted across multiple industries nationwide. Heavy duty.

Disposable Nitrile Gloves - Blueflame Medical

Description. Disposable Nitrile Gloves are a critical piece of personal protective equipment (PPE.) Used during medical procedures and examinations, nitrile gloves protect both the wearer and the patient from the spread of disease, such as Covid-19. Nitrile gloves are also highly chemical and puncture resistant.

Examgards® Examination Blue Nitrile Disposable Gloves ...

Exam Grade gloves feature a tight, form-fitting design; These gloves may be used for non-surgical medical tasks and for foodservice tasks; Each pair is 2.5 AQL and 510(k) cleared for medical use; Exam Grade gloves are non-sterile; Exam Grade quality …

Sterile Nitrile Gloves at Thomas Scientific

Sterile Pair Packed Nitrile Gloves USP 797 Compliant TechNiGlove Pair Packed Sterile 12" gloves are Technicleaned for Class 100 compatibility and sterilized by gamma irradiation to meet AAMI and ASTM standards. They are approved for use in both USP797 and chemotherapy applications.

Disposable & Clean Room Gloves | Dillon Supply

510K Medical Non-Sterile Nitrile Gloves, X-Large, 100/box. 05816630 MFG #: 510K XL. ... Ansell Microflex® N863 Integra® N86 Non-Sterile Single Use Disposable Gloves, L, Nitrile, Blue, 9-1/2 in L, Non-Powdered, Fully Textured, 6.7 mil THK, Application Type: Exam/Medical Grade, Ambidextrous Hand ... Fill out my online form. ...

ValiantN3101 Series Nitrile Gloves:Personal Protective ...

Valiant™ N3101 Series Nitrile Gloves Fingertip textured nitrile gloves are ideal for applications within Healthcare, Labs, EMS and other settings where high-use and disposable exam glove protection is …

Nitrile Examination Disposable Gloves:Personal Protective ...

Nitrile Examination Disposable Gloves Disposable nitrile gloves, powder free, non-sterile, ambidextrous $17.50

N300 Series Nitrile Exam Gloves - AED Superstore

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K183562 Device Name Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs Indications for Use (Describe)

Nitrile Gloves – Vina1Global

Nitrile Gloves. Functional Benefits. Non-Sterile Disposable gloves carry a heavy burden within your operating room. protect the wearer and the patient from contamination. Protection from unwanted and dangerous substances. Beaded cuff ensures easy donning and prevent roll down. Superior strength with better puncture resistance.

Class 100 Nitrile Gloves at Thomas Scientific

TechNiTote Portable Dispenser with Blue, Class 100, Nitrile Gloves, 12" Length. The TechniTote is a plastic clamshell dispenser of Class 100 nitrile gloves for use in applications requiring a clean, portable dispenser. The TechniTote was developed in response to …

DEPARTMENT OF HEALTH & HUMAN SERVICES Public …

Predicate Device Name: Non-Sterile On Line Powder Free Nitrile Blue & White Color Examination Glove] Predicate 510(K) number: K052502 Manufacturer’s Name: YTY Industry (Manjung) Sdn Bhd Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan

Blue Nitrile Gloves – Saen Gloves

Blue Nitrile Gloves. Contact Us. Phone : +66 823 0487 29. WhatsApp : +66 823 048 729. Address : 352 kanjanavait Road, Pahtong, Hat Yai Songkhla 90230, Thailand. Blue Nitrile Gloves. The Nitrile Disposable Gloves is suitable for medical , non medical , packaging, food industry and other janitorial purposes. The gloves come in two surfaces:

Exam Grade Gloves - Nitrile Equivalentâ Blue Disposable â ...

Exam Grade Gloves - Nitrile Equivalentâ Blue Disposable â Box of 100 - Size Large. Average ... Add to cart. Add to list. Add to registry. Nitrile Disposable Black Gloves, 4 Mil, Non Sterile, Powder Free, Latex Free, Large Size, Box of 100. $19.99 $ 19. 99 - $35 ... Grade: Exam - 510k - ASTM D6319; Available in Small to X-Large; Packed: 100 ...

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

510(K) Certified. The FDA requires specific certifications for medium-risk medical devices like disposable gloves. A premarket notification, or 510(k) certificate, acts as a way to verify that a new medical device is substantially equivalent to a device that’s already received approval for sale in the United States. Look for a 510(k ...