nitrile gloves powder free 510k instructions

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(FDA 510k) Sri Trang Codi-M Powder-Free Nitrile Exam Gloves- nitrile gloves powder free 510k instructions ,Product Details CODiM GLOVE (Medical) Non-sterile, Powder-Free Nitrile Examination Glove - Ocean Blue. Tested for use with Chemotherapy Drugs and Fentanyl. FDA 510(K) K200539. Patient Examination Glove ASTM D6319. Nitrile Butadiene Rubber gloves caters to individuals with Type I Allergic reaction. Non-powdered NBR (NitN80-10 Powder-Free Nitrile Exam Gloves - Scientific ...N80-10 Nitrile exam gloves Additional Standards and Certifications: ASTM D6319, US QSR/FDA 510 (K). Packaging Specifications: 100 gloves in a box; 10 boxes per carton. White N80-10 nitrile exam gloves. White nitrile gloves give great protection and splash resistance to chemicals. 100% nitrile construction eliminates the risk of latex protein ...



December 21, 2018 Shanghai Truthful Information Technology ...

510(k) number: K171422 . 5.0 Indication for Use The Nitrile Glove Powder Free White is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. 6.0 Device Description The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is white.

510(k) Premarket Notification

Jun 28, 2021·polymer patient examination glove: 510(k) Number: K202384: Device Name: Palm Care Blue Nitrile Examination Gloves Powder Free: Applicant: Hi-Care Thai Gloves Co. Ltd. 199Moo.11, T.Banpru: hat yai, TH 90250 Applicant Contact ... see Instructions for Downloading Viewers and …

Gloves – Alliable Medical

Non Sterile Powder Free Nitrile Gloves. Alongside our latex glove, Alliable Medical offers a Non-Sterile Powder Free Nitrile Glove that is FDA 510K cleared and proved to be the standard for the highest quality. Certifications: FDA 510K Cleared IISO 9001:2008 ISO 1345:2003 IISO 22000: 2005 CE Marking Our glove is offered in (4) sizes :

Standard Specification for Nitrile Examination Gloves for ...

U.S. Pharmacopeia for absorbable dusting powder may be applied to the glove. Other lubricants may be used if their safety and efficacy have been previously established. 4.3 The inside and outside surface of the nitrile rubber examination gloves shall be free of talc. 5. Sampling 5.1 For referee purposes, gloves shall be sampled from finished ...

BESTSAFE NITRILE Powder Free Examination gloves » ANV ...

BESTSAFE NITRILE Powder Free Examination gloves SPECIFICATION. Protection from unwanted and dangerous substances. Beaded cuff ensures easy donning and prevent roll down. Superior strength with better puncture resistance. Full textured or Finger Tip textured enhances wet and dry grip. Thinner gauge improves tactile sensitivity.

510(k) Premarket Notification - accessdata.fda.gov

510(K) Number. Decision Date. ... encore latex ortho, powder free latex surgical gloves with protein content labeling claim (50µg/dm2 per glove of total aqueous extractable protein) and tested for use with chemotherapy drugs, gammex ... powder free black nitrile examination glove: Vietglove Corporation K201428: 06/24/2021 renamel bulkfill ...

Gloveon Paloma Nitrile Powder Free Examination Gloves FDA 510K

Gloveon Paloma Nitrile Powder Free Examination Gloves FDA 510K (#1891), NB 30 NB 32 AvailableOrigin: MalaysiaPowder-free, Chemo drug tested, Lab...

Proguard Nitrile Examination Gloves - Latex & Powder Free

Proguard Nitrile Examination Gloves are high quality, medical grade gloves made from premium nitrile. Proguard is produced in a FDA 510k approved facility and has European approval as an Examination glove that protects against virus and other contaminants. Our unique nitrile blend, sourced from Japan, is chemical, abrasion, and tear resistant.

(Chemo-Tested, FDA 510k) Medline FitGuard Powder-free ...

Product Details These are violet-blue, powder-free, latex-free nitrile exam gloves manufactured by Medline and branded by FitGuard. Offer excellent sensitivity for touch perception and dependable protection 3.6 mil at finger, 2.8 mil at palm Textured fingertips for enhanced grip Color-coded sizing on each box helps you

Nitrile Powder-Free Examination Gloves

Nitrile Powder-Free Examination Gloves NON-STERILE Along with the durability and strength of nitrile, these gloves were tested using ASTM standards for permeation against 65 chemotherapy drugs and chemicals* Their ambidextrous design with textured fingertips and beaded cuff ensure a sturdy, . comfortable product, combining safety and tactile sensitivity.

510(k) Premarket Notification - accessdata.fda.gov

510(K) Number. Decision Date. ... encore latex ortho, powder free latex surgical gloves with protein content labeling claim (50µg/dm2 per glove of total aqueous extractable protein) and tested for use with chemotherapy drugs, gammex ... powder free black nitrile examination glove: Vietglove Corporation K201428: 06/24/2021 renamel bulkfill ...

FreeStyle1100 Nitrile Exam Gloves - Hourglass ...

Accelerator-Free Nitrile Gloves with Great Grip! HandPRO ® FreeStyle1100™ Nitrile Exam Gloves with Low Dermatitis Potential are highly flexible and conform to the hand for exceptional freedom of movement. Made from the patented LOW DERMA TM accelerator-free nitrile, this powder-free glove has fewer chemicals and virtually eliminates the risk of Type I latex and Type IV chemical allergic ...

Fact Sheet: Disposable Nitrile Gloves in Chemical Labs ...

Fact Sheet: Disposable Nitrile Gloves in Chemical Labs. Original version 12/2018, Revised 1/2019, 3/2019, 3/2021. Note: For the purpose of this Fact Sheet, the term "disposable nitrile gloves" refers to gloves that are one-time use and have a thickness of 5-mil and less. Examples are given in the tables at the end of the fact sheet.

Powder Free Nitrile Gloves, Tronex Nitrile Gloves

So Nitrile will typically last longer for applications where those possibilities exist over Powder Free Latex Gloves. Tronex Gloves are FDA 510(k) Approved for Medical Use. Tronex Gloves Meets and exceeds ASTM 6319. Tronex Gloves Meets and exceeds ASTM F1671, and Tronex Powder free nitrile Gloves meet and Exceeds ASTM D6978

Hongray - Nitrile Exam Gloves - Powder Free - FDA 510K ...

100% latex-free and powder-free nitrile examination gloves offering better protection and durability to the wearer. Made using premium-quality synthetic nitrile rubber, these gloves offer excellent puncture resistance, chemical resistance and anti-bacterial penetration, providing better protection to the wearer.

510(k) Premarket Notification

Device Classification Name. polymer patient examination glove. 22. 510 (k) Number. K193666. Device Name. Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff. 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.

FDA 510 k Submission for Latex and Nitrile gloves ...

A 510 k clearance is mandatory for examination and surgical gloves to market in the USA. FDA review time for a 510 k notification is 3 months, but in reality, it may take 6 months or more depends how perfect your 510k documentation is. FDA published guidance documents for latex and nitrile (examination and surgical) gloves 510k submission.

(FDA 510k) SunnyCare Blue Powder-free Nitrile Medical Exam ...

Instructions for use are on the product package. Packaging. Configuration: 100 gloves/box, 10 boxes/case. Each case of 1000 contains 10 boxes x 100 pc/box. (FDA 510k) SunnyCare Blue Powder-free Nitrile Medical Exam Gloves

Synguard Nitrile Exam Gloves, Blue, Box of 100

Synguard Nitrile Exam Gloves, Blue, Box of 100. Comfortable, super soft flexible powder-free nitrile gloves provide added safety in many applications. Designed with a special nitrile formulation they feel and fit like latex and allow full range of motion and excellent flexibility to minimize stress and fatigue.

Safeko Nitrile Disposable Gloves - Blue - Powder Free ...

Exam Grade - 510k - ASTM D6319. Box of 100. Safeko's Nitrile Standard Exam Grade gloves are a versatile, powder-free glove used for numerous industries. Great for tasks requiring good puncture resistance and a high level of dexterity, these powder-free gloves, make them a non-irritant to your skin, and a more resilient glove for you to use.

AnsellTouch N Tuff Disposable Nitrile Gloves, Powder-free ...

Proven splash resistance against hazardous chemicals. Ansell Edmont Touch N Tuff™ Disposable Nitrile Gloves provide a comfortable fit and minimize hand fatigue. Offers exceptional resistance to nuisance punctures, nicks, cuts and abrasions. Splash protection against irritating chemicals. Made from 100% nitrile for superior elasticity.

510(k) Premarket Notification - accessdata.fda.gov

510(K) Number. Decision Date. ... encore latex ortho, powder free latex surgical gloves with protein content labeling claim (50µg/dm2 per glove of total aqueous extractable protein) and tested for use with chemotherapy drugs, gammex ... powder free black nitrile examination glove: Vietglove Corporation K201428: 06/24/2021 renamel bulkfill ...

3M™ Multi-Purpose Nitrile Examination Gloves Model NT400PF ...

Made from 100% Nitrile; Latex free, powder free, odor free and non-tacky; Ambidextrous; Safety standard: EN 374, EN 455, FDA 510(k) registered; For the widest range of tasks where you need reliable strength, flexibility, and chemical resistance; Perfect for precision works with excellent grip and durability