sterile nitrile gloves blue 510k form instructions

510(k) Premarket Notification

21-06-2021·polymer patient examination glove: 510(k) Number: K181857: Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Applicant

Medical Gloves | FDA

Medical gloves are examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations.

Kimberly-Clark™ Smooth Blue Nitrile Exam Gloves …

When your lab or facility’s workers need protection against moderate to high exposure to fluids or chemicals along with excellent tactile sensitivity, Kimberly-Clark Smooth Blue Exam Nitrile Gloves are an excellent choice. The smooth finish offers sensitivity with superb fit and comfort. The beaded cuff provides added strength and makes donning easier.

BioClean™ Nitrile Sterile RABS/Isolator Gloves GGL | Blue ...

30-03-2020·Glove length (mm/inches): 840/33; Internal glove surface: power-free, chlorinated; Material: nitrile; Shape: ambidextrous; Port sizes: 6″, 8″, 10″ & 12″ Cleanroom Class: class 10/ISO 4 & Eu Gmp Grade A; Sterile: yes; Tested for use with chemotherapy drugs: yes, in accordance with ASTM D6978 (not listed in the US FDA 510K) Palm Thickness (mm/mil): 0.50/20; Finger Thickness (mm/mil): …

IconGlove | Nitrile Medical Examination Gloves and Latex ...

Sterile Latex Surgical Gloves. ... Nitrile: Color: Blue: Glove Design: External surface: fingertip/palm textured, polymerized ... EN455-2:2015, EN455-4:2009, ASTM D6319, ASTM D3578, FDA 510K, ISO 9001/13485: Storage Instructions: It is recommended to store the gloves in dry place, ...

Medical Gloves | FDA

Medical gloves are examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations.

Examination Nitrile Glove by Medcellence. Supplier from ...

Item No. : NG35-100 Blue, 3-5mil Description : Disposable Examination Nitrile Glove Size/ Weight : S 3.0g M 3.5g L 3.8g XL 4.1g Color : Blue Material : Nitrile Carton Size : 31.5*25.8*24.5 cm Case Pack : 100 pieces / box, 10 boxes / carton Price Per Unit : $51.75 for 1000 Gloves Moq Based Prices : $51.75/ 100000 $50.60/ 500000 $49.45/ 1000000 Payment Terms : 100% Advance Payment Lead Time : 7 ...

Nitrile Examination Disposable Gloves:Personal Protective ...

Fisher Scientific - Disposable nitrile gloves, powder free, non-sterile, ambidextrous Shop Nitrile Examination Disposable Gloves at Fishersci

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.

gloves industrial nitrile sterile latex

Latex Free Exam Gloves | Industrial Gloves - Nitrile Gloves. Ultraform PF Nitrile Exam Gloves, $19.99 per 100 gloves, 10 boxes of 300 per case. The unique soft formulation of our Ultraform PF Nitrile Exam Gloves forms to your hand effortlessly as if it was a second skin.

Blue Nitrile Gloves | 24medical

Disposable nitrile gloves protect your hands from contamination and from contact with harmful substances and pathogens. Nitrile gloves are latex-free disposable gloves, well tolerated by the skin and suitable for allergy sufferers with sensitive skin. Gloves made of nitrile rubber have good material properties. Blue nitrile gloves are mainly used in the food industry and hospitals.

Glove Use Information Leaflet - WHO

sterile gloves are indicated. Hand hygiene should be performed when appropriate regardless of indications for glove use. PAGE 3 OF 4. GLOVE USE INFORMATION LEAFLET All reasonable precautions have been taken by the World Health Organization to verify the information contained in …

Medical Glove Guidance Manual - Guidance for Industry and ...

Guidance for Industry and FDA Staff . Medical Glove Guidance Manual . Document issued on January 22, 2008 . This document supersedes Guidance for Medical Gloves – A Workshop

Glove Use Information Leaflet - WHO

sterile gloves are indicated. Hand hygiene should be performed when appropriate regardless of indications for glove use. PAGE 3 OF 4. GLOVE USE INFORMATION LEAFLET All reasonable precautions have been taken by the World Health Organization to verify the information contained in …