nitrile chemotherapy gloves fda 510k guidelines

March 2020 510(K) Clearances | FDA- nitrile chemotherapy gloves fda 510k guidelines ,March 2020 510(K) Clearances. March 2020 510(K) Clearances ... Medline Sterile Powder-Free Nitrile Examination Gloves ... 11-MAR-20 Racine WI 53404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ...FDA 510(k) Applications for Medical Device Product Code ...fda 510(k) number: applicant: device name: decision date: k841676: abco dealers, inc. disposable poly gloves: 05/22/1984: k972195: absolute synthetic technologies malaysia sdn. bhd. powder-free nitrile examination glove, blue or white (non-colored) 07/29/1997: k972838: absolute synthetic technologies malaysia sdn. bhd.



510(k) Premarket Notification

Jan 25, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K200539: Device Name: Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl

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FDA 510(k) Applications Submitted by Ansell Healthcare ...

FDA 510(k) Number Submission Date Device Name Applicant; K092327: 08/04/2009: MICRO-TOUCH NITRA FREE: ANSELL HEALTHCARE PRODUCTS LLC: K093523: 11/13/2009: MICRO-TOUCH NITRILE: ANSELL HEALTHCARE PRODUCTS LLC: K200671: 03/13/2020: Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink …

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Kimberly Clark Purple Nitrile Gloves USP 800 ASTM Chemo Use

Kimberly Clark KC500 series purple nitrile gloves are our most popular non-sterile lab glove. These gloves are not for use in ISO5 Class 100 clean rooms since they come boxed, however they are chemo-rated and suitable for use in less strict ISO7-8 clean rooms.

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Kimberly Clark Kc500 Chemotherapy Nitrile Gloves by ...

Product - Kimberly-Clark KC500 Purple Nitrile Powder-Free Exam Gloves (100pcs/box) Capacity - 10,000,000 boxes / month Certification - CE, FDA 510(k), ASTM D6978-05 Price Range - USD 8.30 / box and above Price subject to market fluctuation. Payment Method - 100% LC

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Wanted : Nitrile Chemo Gloves. Buyer from Canada. Lead Id ...

Please quote for the following wholesale product requirement - Product Name: Nitrile Chemo Gloves Specifications: - FDA 510k 100% Nitrile Chemo Gloves (Blue) Fentanyl Resistant - ASTM D6978-05 Quantity Required : 1000000 Box/Boxes Shipping Terms : CIF Or FOB Destination Port : United States Payment Terms : To be discussed with suppliers Looking for …

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FDA 510(k) Applications Submitted by TOP GLOVE SDN. BHD.

fda 510(k) number submission date device name applicant; k913409: 07/30/1991: latex examination gloves: top glove sdn. bhd. k122999: 09/27/2012: powder free nitrile examination gloves, tested for use with chemotherapy drugs: top glove sdn. bhd. k990468: 02/16/1999: latex examination glove w/ low protein labeling: top glove sdn. bhd. k021855: 06 ...

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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 ...

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510(k) Premarket Notification

Jan 25, 2021·Device Classification Name: surgeon's gloves: 510(k) Number: K171279: Device Name: Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves

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510(k) Premarket Notification

Jan 25, 2021·Device Classification Name: surgeon's gloves: 510(k) Number: K171279: Device Name: Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves

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China FDA 510 (K) Applications Submitted by Hartalega Ngc ...

Examination Latex Gloves, Nitrail Examination Gloves, Surgical Gloves manufacturer / supplier in China, offering FDA 510 (K) Applications Submitted by Hartalega Ngc Sdn. Bhd, Italian Army Patch, PVC Rubber Patch for Military Purpose, Army Uniform Shoulder Patch, 1mm Thickness 3D Silicone Heat Transfer Brand Labels for Suits and so on.

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

Jun 15, 2020·The FDA does not intend to object to the distribution and use of patient examination gloves that do not comply with the following regulatory requirements, where the 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 807.81,26 ...

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510(k) Premarket Notification

Jan 25, 2021·510(k) Number: K182241: Device Name ... Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs: Applicant: Sri Trang Gloves (Thailand) Co., LTD: 10 Soi 10 Phetkasem Road: hatyai, TH 90110 Applicant Contact: anan pruksanusak: ...

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Gloveon Paloma - Nitrile Exam - Powder Free - FDA 510K

Hartalega Paloma, Paloma Nitrile Glove, Hartalega Gloveon Paloma manufacturer / supplier in China, offering Gloveon Paloma - Nitrile Exam - Powder Free - FDA 510K, Badge Maker Custom Embossed 3D Brand Name Logo Silicone Patches Label Rubber Plastic PVC Badge for Uniform Arm, Custom Design 3D Embossed Army Uniform Soft Metal Arm Badges and so on.

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CARDINAL ESTEEM COMFORT - NITRILE EXAM GLOVES - Powder ...

Cardinal Health ESTEEM COMFORT™ Nitrile exam gloves is the newest generation of Esteem™ stretchy nitrile exam gloves. This glove is the perfect combination of improved elongation with outstanding protection from chemotherapy drugs and an FDA approved low dermatitis potential claim. Contact an agent for availability and quotes.

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Kimberly Clark Purple Nitrile Gloves USP 800 ASTM Chemo Use

Kimberly Clark KC500 series purple nitrile gloves are our most popular non-sterile lab glove. These gloves are not for use in ISO5 Class 100 clean rooms since they come boxed, however they are chemo-rated and suitable for use in less strict ISO7-8 clean rooms.

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510(k) Premarket Notification

Jan 25, 2021·510(k) Number: K182241: Device Name ... Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs: Applicant: Sri Trang Gloves (Thailand) Co., LTD: 10 Soi 10 Phetkasem Road: hatyai, TH 90110 Applicant Contact: anan pruksanusak: ...

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CE/ FDA 510K INTCO medical nitrile examination gloves

• FDA 510(K) Available • Approved to use with Chemotherapy Drugs 1.100% latex free-made from durable,puncture resistant, protein and powder- free nitrile,eliminates the Type I allergic reaction associated with natural rubber latex 2.Highly elastic and super soft 3.Rolled rim to facillitate easy donning 4.Designed to give a natural rubber ...

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FDA Relaxes Enforcement Policies for Medical Gowns and Gloves

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 …

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Nitrile Gloves - mecmedicare.cn

free nitrile gloves offer quality resistance to chemicals and have a form-fitting ... The gloves are ambidextrous and tested for use with chemotherapy drugs. - Latex free - Powder-free - Rolled rim to facilitate easy donning ... FDA 510(k) Standards Extra small, Small, Medium, Large and Extra large Sizes Blue, Black or White

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CARDINAL ESTEEM COMFORT - NITRILE EXAM GLOVES - Powder ...

Cardinal Health ESTEEM COMFORT™ Nitrile exam gloves is the newest generation of Esteem™ stretchy nitrile exam gloves. This glove is the perfect combination of improved elongation with outstanding protection from chemotherapy drugs and an FDA approved low dermatitis potential claim. Contact an agent for availability and quotes.

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China FDA 510 (K) Applications Submitted by Hartalega Ngc ...

Examination Latex Gloves, Nitrail Examination Gloves, Surgical Gloves manufacturer / supplier in China, offering FDA 510 (K) Applications Submitted by Hartalega Ngc Sdn. Bhd, Italian Army Patch, PVC Rubber Patch for Military Purpose, Army Uniform Shoulder Patch, 1mm Thickness 3D Silicone Heat Transfer Brand Labels for Suits and so on.

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FDA 510(k) Applications Submitted by TOP GLOVE SDN. BHD.

fda 510(k) number submission date device name applicant; k913409: 07/30/1991: latex examination gloves: top glove sdn. bhd. k122999: 09/27/2012: powder free nitrile examination gloves, tested for use with chemotherapy drugs: top glove sdn. bhd. k990468: 02/16/1999: latex examination glove w/ low protein labeling: top glove sdn. bhd. k021855: 06 ...

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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.

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Nitrile Examination Gloves, FDA 510(k) - 0% Down - Spartan

Nitrile Examination Gloves, FDA, 510(k) As your medical supply partner, we represent proven manufacturers of trusted Nitrile Glove brands, providing a simple, comprehensive solution to deliver the protective equipment you need at competitive prices.

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