nitrile chemotherapy gloves fda 510k guidance

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nitrile chemotherapy gloves fda 510k guidance

High Elasticity:
Stretch Resistance

Thick Design:
Puncture Resistant

Sealed &Waterproof:
Care for Your Hands

Latex and allergy free:

These gloves have latex free materials that are useful for those people who have allergy to the latex. 

Puncture resistant:

Nitrile gloves are specifically manufactured in a puncture-proof technology. 

Full-proof sensitivity:

These are produced to fulfill sensitivity requirements.

Kimberly Clark Purple Nitrile Gloves USP 800 ASTM Chemo Use- nitrile chemotherapy gloves fda 510k guidance ,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.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.



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 ...

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.

gatamo

Company Profile. Factory introduction. GATAMO group has passed ISO9001 quality management certification,Vinyl and Nitrile gloves have been obtained FDA 510K certificate, EU CE certificate, EN374 test and European food safety test, Nitrile gloves have also passed the CHEMO test.

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

Nitrile Textured - Bosma

Complies with FDA Biocompatibility Guidance for ... Passes viral penetration test (ASTM F1671) 510K / Approved for medical use Component materials comply with FDA regulations for food contact Tested for use with chemotherapy drugs in accordance with ASTM D6978 ... EXAMINATION GLOVES Nitrile …

Nitrile Examination Gloves – J7 International Inc.

wimax hg pro - nitrile exam gloves - fda 510k - chemo rated $0.00 Wimax nitrile examination gloves are an excellent solution with specifications that accommodate a broad spectrum of …

Medical Glove Guidance Manual | FDA

FDA is assessing how to revise this guidance to represent our current thinking on medical gloves. This manual provides FDA’s recommendations for Premarket Notification (510(k)) submissions for ...

Strategies for Optimizing the Supply of Disposable Medical ...

Dec 23, 2020·Research has shown multiple disposable latex and nitrile glove brands maintained their integrity when treated with ABHS.[1-3] Disposable medical gloves can be disinfected for up to six (6) applications of ABHS or until the gloves become otherwise contaminated or ineffective (for one or more of the reasons stated in extended use guidance above).

FDA 510(k) Applications Submitted by Sri Trang Gloves ...

FDA 510(k) Number Submission Date Device Name Applicant; K182241: 08/20/2018: Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs: Sri Trang Gloves (Thailand) Co., LTD

9117 Series Nitrile “NEW AGE®” Chemo-Rated, Powder-Free ...

FDA 510(k) Approved for Medical Use; 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

China Hartalega Paloma FDA 510K - China Hartalega Paloma ...

China Hartalega Paloma FDA 510K, Find details and Price about China Hartalega Paloma, Paloma Nitrile Glove from Hartalega Paloma FDA 510K - Nanjing Angela Accessories Co., Ltd. ... Powder free, Chemo drugs tested,Lab chemical tested, Violet blue colour and Thickness-2.7mil ... Blue Nitrile Gloves USA OTG 3M 1860 ...

Kimberly-Clark™ Purple Nitrile™ Exam Gloves (55082), 5.9 ...

Your valuable employees deserve the worry-free protection of Kimberly-Clark Purple Nitrile Exam Gloves. These purple nitrile gloves guard against incidental splashes, are made of a highly durable nitrile polymer and are powder free and not made with natural rubber latex (some say “latex free”). The gloves are a 9.5” long, are ambidextrous and have a beaded cuff for easy donning.

510(k) Premarket Notification

Jan 18, 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)

Evaluating Chemotherapy Protection for Exam Gloves

of protection they are using. The Food and Drug Administration (FDA) offers specific guidance when it comes to labeling exam gloves for chemotherapy. The excerpt below comes from the FDA’s Glove Guidance Manual 2008: To market the glove for use in the handling and/or preparation of chemotherapeutic

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.

510(k) Premarket Notification

Jan 18, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K193581: Device Name: Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy …

Nitrile Exam Gloves | Chemo-rated Nitrile Exam Gloves ...

Additionally, all Tronex chemotherapy-rated nitrile exam gloves meet and exceed ASTM D6978 Resistance of Medical Gloves to Permeation by Chemotherapy Drugs with FDA 510(k) Approved for Medical Use. 9250/9252 Series Nitrile Powder-Free, Fingertip-Textured Exam Gloves

Nitrile Medical - PSG, INC.

Medical Grade ~ Latex-Free ~ Textured ~ Powder-Free ~ FDA 510k Certified. Our entire Nitrile Medical Grade Examination Glove Portfolio is manufactured under ISO 9001:2008 & conforms to International Quality Standards ASTM D6319, D6124, D5151, EN 455 & 510k Certified.

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.

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.

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.

March 2020 510(K) Clearances | FDA

March 2020 510(K) Clearances. March 2020 510(K) Clearances ... 30-MAR-20 Ivyland PA 18974 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ... Medline Sterile Powder-Free Nitrile Examination Gloves ...

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 ...

Nitrile Gloves – Global Gain Enterprises

Quality: conforming to ASTM – D3578-01 ae2 and FDA 510 (K) Conforming to EN455 part 1-3 mm. ADDITIONAL INFORMATION: Nitrile gloves 100 pieces / box FDA HS certificates 40151900. EC, KCS, EN388, EN511, EN374-1, EN420, EN407, EN374-5, ANSI. SIZEs: S, M, L. NITRILE MATERIAL Powder / latex free. Finger thickness> 0.16 mm. Palm> 0.13 mm. Wrist> 0 ...