medical nitrile gloves 510k medical device fda

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Gloves – Alliable Medical- medical nitrile gloves 510k medical device fda ,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 : Small, Medium , Large, X-Large.FLEXAL™ Nitrile Medical Gloves | Cardinal HealthFootnotes and references: *GHX/ HPIS D_MAT2015 1 Caution: Gloves used for protection against chemotherapy drug and laboratory chemical exposure should be selected specifically for the type of chemicals being used. 2 This Cardinal Health product helps healthcare facilities comply with the USP <800> standard for the safe handling of hazardous drugs.. Note: Review Safety Data Sheets (SDS) …



KIMBERLY CLARK KC500 Purple - Nitrile Examination Gloves ...

Kimberly Clark Nitrile Examination Gloves are market-leading medical examination gloves. A high-performance medical examination nitrile glove approved for chemotherapy manufactured by Kimberly Clark, one of the world's leading producers of nitrile gloves. Do you have questions about product orders? Contact our team to review our range of secure supply solutions.

How to Import Nitrile Gloves | USA Customs Clearance

Mar 27, 2020·Does the FDA Require a 510K For Nitrile Gloves? Nitrile gloves, including for surgical use, are categorized as class 1 medical devices. This means they’re regulated by the FDA and require a 510(k) premarket notification. The FDA reviews the gloves to insure that they meet specific criteria related to safety and performance.

Disposable Nitrile 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.

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

FDA 510(k) Applications for Medical Device Product Code "LZA" (Polymer Patient Examination Glove) FDA 510(k) Number: Applicant: Device Name: Decision Date: K841676: ... EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM: 10/07/2014: K193121: ECO Medi Glove SDN BHD: GEN 2 Nitrile Examination Glove (Blue) With Low ...

510(k) Premarket Notification

Jan 25, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K200671: Device Name: Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for

510(k) Premarket Notification

Jan 25, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K091652: Device Name: NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS

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

fda 510(k) number: applicant: device name: decision date: k893834: accurate medical devices, inc. accumed latex surgical glove: 12/14/1989: k892499: advance rubber, inc. safety surgeons gloves: 10/11/1989: k932061: advanced chemical technology, inc. miracle glove under the glove gloving cream: 11/16/1993: k891621: albors-menconi latex corp ...

Nitrile Examination Gloves – J7 International Inc.

Nitrile Examination Gloves for dental, medical, laboratory and other applications. High quality and supplied under medical device license. FDA, CE, ISO compliant. Excellent solution for professional, industrial or personal use.

510(k) Premarket Notification

Jan 25, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K200072: Device Name: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid

Nitrile Glove Hub | 5StarMedical Corp

Numerous professions rely on the durability of Nitrile gloves, particularly when exposure to blood-borne pathogens and other environmental contaminants are of concern. Our Nitrile gloves are FDA approved for medical use and are highly cut-resistant, giving incredible durability and barrier protection.

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

FDA 510(k) Number: Applicant: Device Name: Decision Date: K904190: 1ST MED, INC. PATIENT EXAMINATION GLOVES: 09/19/1990: K910542: 21ST CENTURY GROUP: DIGIFLEX, LATEX ...

FLEXAL™ Nitrile Medical Gloves | Cardinal Health

Footnotes and references: *GHX/ HPIS D_MAT2015 1 Caution: Gloves used for protection against chemotherapy drug and laboratory chemical exposure should be selected specifically for the type of chemicals being used. 2 This Cardinal Health product helps healthcare facilities comply with the USP <800> standard for the safe handling of hazardous drugs.. Note: Review Safety Data Sheets (SDS) …

Looking For Disposable Medical Nitrile Glove Powder Free ...

An importer from Mexico is looking for the suppliers of Safety Gloves. Hello, for now, we need 30,000 Boxes (100pcs/Box) of Medical Nitrile Gloves. Please quote your best price delivered to Texas, USA

FDA Registration of Latex and Nitrile gloves - fdahelp.us

16 行·FDA regulate latex and nitrile gloves (examination and surgical) as medical devices. Even …

Disposable Nitrile 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.

Medical Nitrile Gloves at Thomas Scientific

…6005PF glove is a 100 percent Nitrile, non-Latex,powder-free medical grade glove which features Best's proprietary beaded and rolled cuff design. The N-DEX 6005PF glove is an ambidextrous, 9.5 inches long, 4-mil thick, packed 2,000 gloves per case. The Class One Medical Examination glove …

510(k) Premarket Notification

Jan 25, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K162405: Device Name: Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)

Nitrile Glove - Nitrile Glove inventory in the US with Low ...

We also have different manufacturers of Nitrile Gloves from overseas and US manufacturing partners. At this price point of $0.14 per Nitrile Glove, the Minimum Order Quantity (MOQ) is 50,000 pieces. This Nitrile Glove inventory complies with FDA 510K, ISO 9001: 2015, ASTM-D-3578, EN455 PART 1 …

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

fda 510(k) number: applicant: device name: decision date: k893834: accurate medical devices, inc. accumed latex surgical glove: 12/14/1989: k892499: advance rubber, inc. safety surgeons gloves: 10/11/1989: k932061: advanced chemical technology, inc. miracle glove under the glove gloving cream: 11/16/1993: k891621: albors-menconi latex corp ...

Nitrile Glove - Nitrile Glove inventory in the US with Low ...

We also have different manufacturers of Nitrile Gloves from overseas and US manufacturing partners. At this price point of $0.14 per Nitrile Glove, the Minimum Order Quantity (MOQ) is 50,000 pieces. This Nitrile Glove inventory complies with FDA 510K, ISO 9001: 2015, ASTM-D-3578, EN455 PART 1 …

Disposable Nitrile 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.

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

FDA 510(k) Number: Applicant: Device Name: Decision Date: K904190: 1ST MED, INC. PATIENT EXAMINATION GLOVES: 09/19/1990: K910542: 21ST CENTURY GROUP: DIGIFLEX, LATEX ...

Medical Nitrile Gloves at Thomas Scientific

…6005PF glove is a 100 percent Nitrile, non-Latex,powder-free medical grade glove which features Best's proprietary beaded and rolled cuff design. The N-DEX 6005PF glove is an ambidextrous, 9.5 inches long, 4-mil thick, packed 2,000 gloves per case. The Class One Medical Examination glove …

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 ...