medical nitrile gloves 510k medical device description

Cooperation partner

Black Nitrile Gloves by MedPride | Discount Medical Supply- medical nitrile gloves 510k medical device description ,Our black nitrile gloves are exam grade, latex-free, powder-free, 510K approved and can be used in medical applications. Features a textured finish for excellent chemical resistance and a great grip. Wearing a pair of black nitrile gloves allows instant hand protection without the visibility of blood, dirt, and other contaminants.Amazon Best Sellers: Best Medical Exam GlovesNitrile Medical Grade Exam Gloves, Powder Free, Latex-Free, 4 MIL, Fingertip Textured, Size Medium - 1 Box of 100 Gloves by Weight 4.8 out of 5 stars 10 $27.99 - $99.95



Importing Medical Gloves to the USA: Info & Regulations ...

Jun 15, 2020·The FDA does not intend to object to the distribution and use of surgeon’s gloves that do not comply with the following regulatory requirements where the surgeon’s gloves do not create an undue risk in light of the public health emergency: prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,31 ...

US FDA 510k and Registration for Gloves - I3CGLOBAL

Sep 21, 2020·A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

FDA 510(k) Applications for Medical Device Product Code ...

rs orange nitrile medical examination gloves (powder free) 06/23/2014: k112924: riverstone resources sdn. bhd. rs safe black nitrile medical examination gloves powder or other proprietary name: 05/02/2012: k100603: riverstone resources sdn. bhd. rs safe blue nitrile medical examination gloves (powder free) 07/16/2010: k112928: riverstone ...

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 Glove - The World's Largest Manufacturer of Gloves

NITRILE EXAMINATION GLOVE. Nitrile Examination Glove is a disposable device intended for medical purposes that are worn on the examiner’s hand to prevent contamination between the patient and examiner. European Countries : Class I Directive MDD 93/42/EEC; United States of America (USA) : Class I with approved 21.CFR.820 FDA 510(K)

Cardinal Health Esteem Nitrile Gloves with Neu-Thera ...

Description. Designed for and tested by healthcare professionals, these gloves are more than just a moisturizer—they are clinically proven to improve the health of your skin. Protect hands from moisture loss; Fully textured with beaded cuffs ; Powder-free, nonsterile; Average length: 9.76 in. (24.8cm)

Nitrile Exam Gloves Medical – 510K - ABOBTECH CO.,LTD

ABOB Nitrile Exam Gloves. Medical – 510K. Overview • Class I Medical Device • Nitrile Medical Exam • Blue • Non-sterile • Powder free • Beaded cuff • Ambidextrous • Single use. Product Description Certification. Related Products. Pure Nitrile Gloves (3, 4, or 6 mil)(Black) Model NO.:ABOB704 . Pure Nitrile Gloves (Non-Medical ...

Cardinal Health Esteem Nitrile Gloves with Neu-Thera ...

Description. Designed for and tested by healthcare professionals, these gloves are more than just a moisturizer—they are clinically proven to improve the health of your skin. Protect hands from moisture loss; Fully textured with beaded cuffs ; Powder-free, nonsterile; Average length: 9.76 in. (24.8cm)

Nitrile Powder Free Examination Gloves (6 mil thickness)

Medical gloves are one part of an infection-control strategy. Medical gloves are disposable and include examination gloves, surgical gloves, and medical gloves for handling chemotherapy agents (chemotherapy gloves). These gloves are regulated by the FDA as Class I reserved medical devices that require a 510(k) premarket notification.

Guidance for Industry and FDA Staff

510(k) submission for surgeon’s gloves should include information about the sterilization method and cycle. The provisions in 21 CFR 801.150(e) regulate the shipment of medical

FDA 510(k) Applications for Medical Device Product Code ...

rs orange nitrile medical examination gloves (powder free) 06/23/2014: k112924: riverstone resources sdn. bhd. rs safe black nitrile medical examination gloves powder or other proprietary name: 05/02/2012: k100603: riverstone resources sdn. bhd. rs safe blue nitrile medical examination gloves (powder free) 07/16/2010: k112928: riverstone ...

Black Nitrile Gloves by MedPride | Discount Medical Supply

Our black nitrile gloves are exam grade, latex-free, powder-free, 510K approved and can be used in medical applications. Features a textured finish for excellent chemical resistance and a great grip. Wearing a pair of black nitrile gloves allows instant hand protection without the visibility of blood, dirt, and other contaminants.

Cardinal Health Flexal&trade Nitrile Gloves:Gloves ...

Description Flexal&trade Nitrile exam gloves are our best-selling exam gloves in our High Use portfolio. They provide tactile sensitivity and protects hands from potentially infectious materials. Certifications. 510K approved for medical use. Compliance. Meets ASTM™ D6319 standards; FDA 510(k) approved for medical use.

gloves nitrile medical 510k fda guidelines

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.

Nitrile Textured Premium Exam Gloves - Universal Medical

Complies with FDA Biocompatibility Guidance for Medical Devices; Passes viral penetration test (ASTM F1671) 510K/Approved for medical use; ISO 9001 Certified QMS; Sold by the Case of 10 Boxes (100 Gloves per Box) Country of Origin: China; Item Availability: Usually ships in 1-2 business days.

NACOSA Nitrile Medical Exam Gloves 4 Mil | Powder-Free/BPA ...

NACOSA Nitrile Medical Exam Gloves 4 Mil are powder-free, BPA-free, and latex-free, and are ON SALE NOW. Buy exam gloves and PPE at Active Forever. ... Description Price; 11201.112113195 : Small $19.75. Out of stock. 11201.112113195 : Small - Case of 1000 ... 510(k) Premarket ...

Nitrile Exam Gloves Medical – 510K - ABOBTECH CO.,LTD

ABOB Nitrile Exam Gloves. Medical – 510K. Overview • Class I Medical Device • Nitrile Medical Exam • Blue • Non-sterile • Powder free • Beaded cuff • Ambidextrous • Single use. Product Description Certification. Related Products. Pure Nitrile Gloves (3, 4, or 6 mil)(Black) Model NO.:ABOB704 . Pure Nitrile Gloves (Non-Medical ...

Bulkbuy 510K Powder Free Disposable Examination Nitrile ...

Bulkbuy 510K Powder Free Disposable Examination Nitrile/Latex/Vinyl Gloves L/C Sign with Factory price comparison, get China 510K Powder Free Disposable Examination Nitrile/Latex/Vinyl Gloves L/C Sign with Factory price comparison from Nitrile Glove,Latex Glove manufacturers & suppliers on Video Channel of Made-in-China.com .

Microflex™ Long Cuff Nitrile Gloves | Fisher Scientific

ISO 9001 Certified QMS.; 510K approved for medical use. Compliance. Complies with FDA Biocompatibility Guidance for Medical Devices. Passes ASTM™ F1671viral penetration test. Tested for use with ASTM F739 chemotherapy drugs. 510K /Approved for medical use.

Medical Gloves for COVID-19 | FDA

A: To identify FDA-cleared medical gloves, search the 510(k) Premarket Notification database using the product codes for medical gloves listed in the previous Q&A. Shortages of Medical Gloves ...

Gloves | MediHands AG

Nitrile Gloves. Medihands is a specialized provider of Nitrile Gloves under its own Medihands brand. These are non-sterile examination and protective gloves for single use, intended for use in the medical field to protect patient and user from cross-contamination, conducting medical examinations, diagnostic and therapeutic procedures and for handling medical contaminated material.

Nitrile Examination Gloves - Medical Powder Free Exam Gloves

High quality Medical Disposable Nitrile Examination Gloves, Powder Free complies with EN455, ASTM-D3578 and D6319.

FDA Relaxes Enforcement Policies for Medical Gowns and Gloves

FDA will look carefully at product labels to determine if medical device claims are being made. Medical Apparel and Gloves. FDA will allow gowns, other apparel and gloves, during this emergency, to be imported without prior 510(k) filings, facility registration and listing requirements, Quality System Regulation (QSR) requirements, or Unique ...

: nitrile medical gloves

Nitrile gloves are used for so many tasks in professional areas as well as personal. They are the best way of keeping your hands sanitary and free of infection, making them ideal for use in medical environments, but also helpful in reducing the possibility of cross-contamination in …