medical nitrile gloves 510k medical device description

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Tronex 9662 - Nitrile Chemotherapy Exam Gloves, 8 Mil ...- medical nitrile gloves 510k medical device description ,* FDA 510(k) Approved as a Medical Device. * Meets and exceeds ASTM D6319 Specification for Nitrile Examination Gloves for Medical Application. * Meets and Exceeds ASTM F1671 Test Method for Resistance of Materials by Blood-Borne Pathogens (Viral Penetration).MAUDE Adverse Event Report: ACE GLOVE (M) SDN BHD ...Event Description Taken from over a dozen reports made by various nursing and medical staff: some of the gloves are just wads of plastic, some are missing fingers, some are discolored. They have weak spots on them, and have broke right off of my hands. In the middle of changing the patient. The gloves ripped, therefore exposed to bodily fluids.



Safeko Nitrile Exam Glove - Chemo Tested | SPHMedical

SPH Medical supplies Nitrile Exam Gloves to Hospitals across the country to protect our frontline healthcare workers. Our industry leading brand Safeko offers a Chemotherapy Drug tested Nitrile Exam glove that provides premium performance, protection and value. The SK-1009 has been tested against 23 Chemo Drugs and Fentanyl.

FDA Permanently Exempts Seven Class I Gloves from 510(k ...

Jan 28, 2021·Through the Notice, HHS identified seven class I devices—all medical gloves—as exempt from the 510(k) premarket notification requirements. The newly exempt gloves include: Device Description

March 2021 510(K) Clearances | FDA

Apr 06, 2021·510 (K) SUMMARIES OR 510 (K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD March 2021 DEVICE: Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) Maxstar Industrial Co ...

Understanding glove certification

All KIMTECH SCIENCE* gloves are PPE Category III certified and compliant with Medical Device standards EN455-1,-2,-3,-4 Protection level against risks Biohazard EN374-1:2003 EN374-1:2003 Virus protection EN374-1: 2003 Material Product code Description EN374-2: 2003 EN374-2: 2003 Level 3 Level 2 0.65 1.5 1.5 1.5 ISO 16604: 2004 Proc. B

510 (K) SUMMARY

510(k)Number: K1< I q-Device Name: Patient Nitrile Examination Gloves, Powder free, Non-Sterile, Blue Color Indications of Use: A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (2ICFR 880.6250)

MAUDE Adverse Event Report: ACE GLOVE (M) SDN BHD ...

Event Description Taken from over a dozen reports made by various nursing and medical staff: some of the gloves are just wads of plastic, some are missing fingers, some are discolored. They have weak spots on them, and have broke right off of my hands. In the middle of changing the patient. The gloves ripped, therefore exposed to bodily fluids.

Quality medical glove For Safety And Hygiene - Alibaba

Medical Gloves Examination Nitrile Gloves Disposable Multifunctional Medical Blue Nitrile Powder Free CE/ FDA 510k Serial Examination Hand Gloves. $0.11-$0.13/ Piece. 1300000 Pieces (Min. Order) CN Shenzhen Highup Science and Technology Co., Ltd. 2 YRS.

510(k) Premarket Notification

Jun 14, 2021·510 (k) Number. K180644. Device Name. Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green. Applicant.

Legacy

Gloves_____ 12 Infection Management _____ 18 Table of Content COMPANY NAME : LEGACY MEDICAL SALES, LLC COMPANY ADDRESS 1565 COPENHAFFER RD. DOVER, PA 17315 Legacy Medical Sales LLC. BE PREPARED Legacy Medical Sales, LLC is your trusted medical device and supply company.

USA: FDA 510(k) permanent exemption for certain Medical ...

Feb 22, 2021·In order to increase the availability of certain Medical Devices in contrast to the COVID-19 health emergency, on January 15, 2021 FDA published a notice in the Federal Register which highlights the relaxation of numerous regulatory, including a waiver of Premarket Notification 510(k) requirements, that is, the Premarket notification requirements under section 510(k).

Synmax HYBRID Exam Gloves | Real Time Pain Relief

BASIC Vinyl/Nitrile Hybrid – Synmax Exam Gloves possess the badge of 510(k) Certified. The 510(k) number is issued once a company has proven that a device is substantially equivalent in performance and safety to other devices already existing on the market. Features Synmax Vinyl Nitrile Hybrid Medical Exam Gloves: Medical Grade; FDA 510(k) Blue

Cobalt Blue Nitrile Exam Gloves, Microflex N19 - Ansell ...

These cobalt blue nitrile exam gloves are used by workers in automotive, electronic assembly, law enforcement, security environments, tattoo shops, beauty salons and healthcare. This glove is 510K approved and can be used in medical applications. Component materials comply with FDA regulations for food contact. The nitrile construction with textured finish offers chemical resistance, great ...

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

Disposable Vinyl Gloves - Blueflame Medical

According to the 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. . . . These gloves are regulated by the FDA as Class I reserved medical devices that require a 510(k) premarket notification.

Biocompatibility tests required for examination and ...

US FDA Medical Device Labeling Requirements - Gloves. US FDA 510K Submission Format. Contents of examination and surgical gloves (Latex / Nitrile) 510k Notification. FDA publish all 510k clearance on fda website, you can find substantial equivalence letter at www.fda.gov. Below are examples of examination and surgical glove 510k clearance letter

Medical Gloves for COVID-19 | FDA

Medical Gloves for COVID-19. Medical gloves are used by health care personnel to prevent the spread of infection or illness. Medical gloves are disposable and include patient examination gloves ...

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.

Sensation® Nitrile Exam Gloves - Box/100 - USA Scientific, Inc

These soft, flexible gloves stretch and conform to your hands, eliminating the stiffness sometimes associated with nitrile gloves. Complies with FDA Biocompatibility Guidance for Medical Devices. ISO 9001 certified. Ambidextrous, non-sterile; approved for medical use (FDA 510k). Microflex brand.

Nitrile gloves - All medical device manufacturers - Videos

Hebei Cangsu Medical Products Technology. nitrile gloves. nitrile gloves. Glove weight: 5.5 g. Glove length: 240 mm. ... Product advantages: Compared with conventional PVC gloves, nitrile Blend gloves can provide more durability, anti-aging ability, and feel softer and more comfortable. Compared ...

Chemo Level Nitrile Exam Gloves

FDA 510(k) Approved as a Medical Device Meets and exceeds ASTM D6319 Specification for Nitrile Examination Gloves for Medical Application Meets and exceeds ASTM F1671 Test Method for Resistance of Materials by Blood-Borne Pathogens (Viral Penetration) Meets and exceeds ASTM D6978 Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

Tronex 9789 - Blue Nitrile Chemotherapy Exam Gloves, Value ...

Tronex chemotherapy tested nitrile medical exam gloves offers excellent barrier protection from bloodborne pathogens, as well as resistance to chemotherapy drugs and other chemicals. * FDA 510(k) Approved as a Medical Device. * Meets and Exceeds ASTM F1671 Test Method for Resistance of Materials by Blood-Borne Pathogens (Viral Penetration).

Medical Device FDA Registration, FDA Clearance

the Federal Food Drug & Cosmetic (FD&C) Act define medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is. (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any ...

Disposable Nitrile Gloves – Kori Medical

KoriMed™ Nitrile Powder-Free Examination Gloves are 510k approved for Medical Use and exceeds ASTM D6319 Specification for Bitrile Examination Gloves for Medical Application, meets and exceeds ASTM D6978 Resistance of Medical Gloves to Permeation by chemotherapy Drugs and manufactured and tested under ISO 9001 and ISO 13485 for Quality Management Systems for Medical Devices.

SKYMED - NITRILE EXAM GLOVES - Powder Free - FDA 510K – J7 ...

SKYMED - NITRILE EXAM GLOVES - Powder Free - FDA 510K. SkyMed nitrile gloves are fully certified and provide a high-capacity supply solution for quality and diverse protection requirements. 3.5g ± 0.2g. 0.07 mm ± 0.2 mm. 0.08 mm ± 0.2 mm.