disposable nitrile gloves blue 510k form template sample example

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Medcare Nitra Force Nitrile Examination Gloves by ...- disposable nitrile gloves blue 510k form template sample example ,Non-Sterile Medical Examination Nitrile Gloves Powder free & Latex free 100% Virgin raw materials with FDA certificate & as per ASTM D6319/ CE EN 455 Quality standard: ASTM D6319, with 510K and FDA, CE/EN455, Color: Blue, white Finger Tips: textured Cuff: Beaded Pcs per Box for S/M/L/XL : 100pcs/box Origin: China, Vietnam, Thailand, Malaysia ...Cranberry Transcend Nitrile Exam Gloves — Cranberry USAThe Transcend Nitrile Powder Free Examination Gloves are Cranberry’s latest and strongest gloves yet, uncompromised superior formulation for high tensile strength without sacrificing tactile sensitivity that is both soft and strong with textured fingertips for precise gripping in dry and wet conditions.



Disposable Laboratory Exam Gloves | Fisher Scientific

Latex-free, nitrile gloves are often thicker than latex gloves, thus making them puncture resistant. Our broad range of disposable nitrile gloves offers different colors, sizes, materials and thicknesses. Choose between powdered and powder-free, medical-exam varieties, and general-purpose options.

510K Summary - Food and Drug Administration

510(k) Number (if known) K 131841 Device Name KIMBERLY-CLARK LAVENDER NITRILE Powder-Free Exam Gloves Indications for Use (Describe) KIMBERLY-CLARK LAVENDER NITRILE Powder-Free Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamnination between patient and examiner.

Blue Nitrile Exam Powder-Free 4 Mil Disposable Gloves (100 ...

AMMEX Blue Nitrile Latex Free Disposable Gloves keep up with and exceed your demands time and time again. Pros measure gloves first on safety, fit, and feel. Top-notch barrier protection against pathogens or contaminants and a fit that conforms to the natural contour of your hand matter most. FDA approved for medical use, they are latex-free ...

Gloves and Hand Protection | Staples

Ambitex® Textured Powder-Free Disposable Nitrile Gloves, Light Blue, XL: 4.5 stars from 201 reviews ($10.79) Ambitex® Textured Powder-Free Disposable Nitrile Gloves, Light Blue, Large: 4.5 stars from 201 reviews ($11.20) Ambitex® Textured Powder-Free Disposable Nitrile Gloves, Light Blue, Medium: 4.5 stars from 201 reviews ($11.41)

Face Masks, Including Surgical Masks, and Respirators for ...

A: Face masks, surgical masks, and respirators all cover a wearer's nose and mouth, but they differ in several aspects. Face masks: A mask, with or without a face shield, that covers the user's ...

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

Great Glove - Soft Nitrile Powder-free Gloves - Box ...

The synthetic fibers Nitrile gloves are derived from allow for increased tear and puncture resistance. Nitrile Gloves also display high tactile sensitivity and form fitting properties. By not containing latex proteins, users who generally experience adverse allergic reactions to latex or natural rubber choose Nitrile as a suitable alternative.

Nitrile Examination Glove

NON DETECTABLE ACCELERATOR* DISPOSABLE NITRILE EXAM GLOVES POWDER FREE NITRILE (ONLINE CHLORINATED) DISPOSABLE EXAM GLOVES ... sample as per ISO 2859-1: Quality Standard: FDA's Quality System Requirement (510K), ISO 9001:2000, ISO I3488, Council Directive 89/686/EEC, NFPA 1999 (Protective Clothing for Emergency Medical Operations, 2003 …

PRODUCT SPECIFICATION Nitrile Powderfree Examination ...

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.

Gloves - Cardinal Health

Our gloves meet industry quality and performance standards because wearer and patient safety are our top priorities. 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.

FDA 510(k) Submission: A Step-By-Step Guide On How To ...

Section 4.0 – Indications for Use statement (FDA Form 3881) and Section 5.0 – 510(k) Summary are what you will find if you go searching the 510(k) database. According to CFR 21 Part 807.95(d) “ FDA will make a 510(k) summary of the safety and effectiveness data available to the public within 30 days of the issuance of a determination that ...

Nitrile Gloves - Safety Zone

NITRILE GLOVES are the perfect compromise between latex and vinyl. Nitrile is made from an allergy safe compound that feels a lot like latex but it’s much stronger, costs less, and is more comfortable to wear. Nitrile is perfect for demanding applications, especially cleaning and dishwashing.

Cranberry Transcend Nitrile Exam Gloves — Cranberry USA

The Transcend Nitrile Powder Free Examination Gloves are Cranberry’s latest and strongest gloves yet, uncompromised superior formulation for high tensile strength without sacrificing tactile sensitivity that is both soft and strong with textured fingertips for precise gripping in dry and wet conditions.

Do Your Gloves Comply with FDA Recommendations and ...

Jun 01, 2017·A well-regarded study conducted in New Zealand under hospital conditions reported the following disturbing information on commercially available disposable nitrile gloves: “ Environmental bacteria, particularly Bacillus species, were present on 31/38 (81.6%) of (disposable glove) samples.

Nitrile Gloves — Cranberry USA

NITRILE CLASSIC. Nitrile gloves are a great alternative for those that are prone to skin irritation and allergic reactions. Nitrile gloves offer the same strong durability and superior level of protection as traditional latex gloves with increased tactile sensitivity, tear resistance, and a more comfortable fit.

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, Nitrile Work GLoves, Nitrile Exam Gloves

Nitrile Gloves Provide More Resistance To Punctures And Greater Protection From Chemicals Than Latex Gloves. ... Nitrile Disposable Gloves (80) Chemical Resistant Nitrile Gloves (16) Powder Type. Powder-Free (76) Powdered (8) ... Help Shipping & Returns Product Recall/Safety Notices International Sales Sales Tax Info W-9 Form Shopping Cart ...

Nitrile Examination Glove

NON DETECTABLE ACCELERATOR* DISPOSABLE NITRILE EXAM GLOVES POWDER FREE NITRILE (ONLINE CHLORINATED) DISPOSABLE EXAM GLOVES ... sample as per ISO 2859-1: Quality Standard: FDA's Quality System Requirement (510K), ISO 9001:2000, ISO I3488, Council Directive 89/686/EEC, NFPA 1999 (Protective Clothing for Emergency Medical Operations, 2003 …

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.

Do Your Gloves Comply with FDA Recommendations and ...

Jun 01, 2017·A well-regarded study conducted in New Zealand under hospital conditions reported the following disturbing information on commercially available disposable nitrile gloves: “ Environmental bacteria, particularly Bacillus species, were present on 31/38 (81.6%) of (disposable glove) samples.

Nitrile Disposable Gloves | AMMEX

Latex-free gloves have the highest chemical and puncture resistance to cover a variety of industries and applications, both exam and industrial grades.

GUIDELINES FOR PERSONAL PROTECTIVE EQUIPMENT (PPE)

Disposable nitrile gloves Lab coat, closed shoes, long pants, long skirt or equivalent leg covering (no shorts) Working with sealed radioactive sources Damaged or leaking source may spread contamination Some leaking sources may pose an external dose risk. Fume hood Bench top shield Minimize exposure time Increase distance to source Safety glasses

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.

How to Import Nitrile Gloves | USA Customs Clearance

Mar 27, 2020·It's important to note that many nitrile gloves have already received approval through a 510K. If you're importing nitrile gloves that have already been approved, then you won't need to go through the 510K process. You'll simply need to reference the 510K to show the gloves you're importing have already been approved.