latex glove fda products list pdf

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latex glove fda products list pdf

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.

FDA 510(k) Applications Submitted by MEDLINE INDUSTRIES, INC.- latex glove fda products list pdf ,SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color: MEDLINE INDUSTRIES, INC. K891791: 03/23/1989: ACCU-TOUCH LATEX EXAM GLOVES, UNISIZE & LARGE: MEDLINE INDUSTRIES, INC. K892075: 04/03/1989: MEDLINE LATEX EXAM GLOVES: MEDLINE INDUSTRIES, INC. K181726 ...Directory of non-medical latex-free product alternativesThis list is intended for guidance only and is intended to assist those wishing to identify whether any non-medical product does or does not contain latex. Please do not rely entirely on this list. We would strongly advise anybody who is interested in purchasing latex free products to obtain



Latex Glove - The World's Largest Manufacturer of Gloves

LATEX GLOVE FOR FOOD HANDLING. Latex Disposable Glove is a disposable device intended for food handling to prevent chemical substances migrating from the food contact material to the food and also to protect food from changes in taste or odor. European Countries: Meet Regulation (EC) No. 1935/2004; More Details Download Brochure Send Enquiry

Regulatory Alert: FDA Import Requirements for Personal ...

Mar 31, 2020·The U.S. Food and Drug Administration (FDA) has provided instruction to the import community via ... • Latex gloves purchased at an auto parts store to be used while changing your car oil ... Below is a list of some products and their FDA product codes that are currently authorized by an EUA. A full list is included in the References section.

in Stock Disposable Nitrile Vinyl Latex Powder Free Glove ...

Nitrile Glove, Vinyl Glove, Disposable Nitrile Glove manufacturer / supplier in China, offering in Stock Disposable Nitrile Vinyl Latex Powder Free Glove Examination Gloves Factory with Ce and FDA En455, Meltblown 100% Cotton Children′ S 3ply Face Mask Dust Mask Three-Layer Protective Mask, Mask for Children and Kids Anti Pollution Comfortable Face Mask and so on.

Product Specs — Cranberry USA

Product Specs & info . Nitrile Gloves I Chloroprene Gloves I Latex Gloves I Vinyl Gloves I Facemasks I Dental Dams . NITRILE GLOVES . Aqua Source CR3440 Series. ... Download Spec Sheets (pdf) Carbon Air CR3260 Series. Download Spec Sheets (pdf) Cerise CR3240 Series. Download Spec Sheets (pdf) Contour CR3110 Series. Download Spec Sheets (pdf ...

E-SHIRUDO

Welcome to E-SHIRUDO ! SHIRUDO, a brand by Cleanera Malaysia Sdn Bhd since 2011, carrying a direction into cleanroom and industrial protection equipment market. With protection in mind, we emphasize quality and effective solutions for you.

Directory of non-medical latex-free product alternatives

This list is intended for guidance only and is intended to assist those wishing to identify whether any non-medical product does or does not contain latex. Please do not rely entirely on this list. We would strongly advise anybody who is interested in purchasing latex free products to obtain

Glove Use in Retail Foodservice Establishments

discarded when removed. Latex gloves are available in a variety of sizes and are sold by the box as well as in case packs (10 boxes of 100 gloves each). Estimated cost is $6.50 per box (6.5 cents per glove). Non-latex gloves look, fit, and perform like latex but without the risks of allergic reactions. They are made from polyethylene and are ...

About Us - ARISTAGLOVES | Personal Care Products

ARISTA LATINDO entered the latex examination glove industry in 1988. ARISTA’s founder, Gentho Sumarta, had a clear vision of excellence and product quality for the company.He believes that ARISTA has a competitive advantage in the industry, arising from Indonesia’s natural latex resources and abundance of labor. He and his team are committed to making ARISTA LATINDO . one of the best ...

(PDF) AN INTRODUCTION TO LATEX GLOVES

The FDA has also proposed a ban on the use of the term "hypoallergenic gl ove" ... latex gloves, and continue ... Latex products are generally produced by a dipping process. Forms

Product Classification - Food and Drug Administration

Jan 18, 2021·10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA

Banned Devices; Powdered Surgeon's Gloves, Powdered ...

(Response 12) Unlike with powdered latex gloves, which have the ability to aerosolize glove powder and carry allergenic proteins, FDA believes the risk of allergic reaction to non-powdered NRL gloves, which affects the user and patients in direct contact with the glove, is adequately mitigated through already-required labeling that alerts users ...

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.

Products|Overview -

is a leading manufacturer of disposable rubber gloves. We provide a comprehensive range of high quality gloves at an efficient low cost.

GUIDELINE TO THE INSPECTION OF HORMONE PRODUCT ...

Drug substance Starting materials, such as excipients and active ingredients, used to make up the final ... 6.1.3 wearing single use, disposable latex gloves. Double gloves should be worn where direct ... active contact cannot be avoided with the product. Gloves should be taped or sealed to the protective suit sleeves; and .

GUIDELINE TO THE INSPECTION OF HORMONE PRODUCT ...

Drug substance Starting materials, such as excipients and active ingredients, used to make up the final ... 6.1.3 wearing single use, disposable latex gloves. Double gloves should be worn where direct ... active contact cannot be avoided with the product. Gloves should be taped or sealed to the protective suit sleeves; and .

:: Our Certificates : Producer of Latex Glove ,Natural ...

Certified PRP is registered and has listed Medical Device with U.S. Food and Drug Administration. Products Latex Patient Examination Glove Polymer Patient Examination Glove. Valid From 20 Febuary 2020. Preview D045943 PDF file. D080681 PDF file. E396728 PDF file.

:: Our Certificates : Producer of Latex Glove ,Natural ...

Certified PRP is registered and has listed Medical Device with U.S. Food and Drug Administration. Products Latex Patient Examination Glove Polymer Patient Examination Glove. Valid From 20 Febuary 2020. Preview D045943 PDF file. D080681 PDF file. E396728 PDF file.

PRODUCT SPECIFICATION FDA 510(k) NO: K970794 …

PRODUCT SPECIFICATION FDA 510(k) NO: K970794 . Patterson Latex PF . PRODUCT Latex examination glove . Polymer coating . Medical grade . Non-sterile . Powder-free . Textured surface . COUNTRY OF ORIGIN Thailand . INTENDED USE This is a disposable device intended for medical purposes that is worn on the examiner’s hand

PowerPoint Presentation

Name of Products Latex Powdered Examination Gloves Latex Powder Free Examination Gloves Nitrile Examination Gloves This certificate is issued upon the request of Mercator Medical (Thailand), Ltd. Thailand. a 19Ju1 01 sri) acist Acting Director of Medical Device Control Division For Secretary-General Food and Drug Administration

(PDF) AN INTRODUCTION TO LATEX GLOVES

The FDA has also proposed a ban on the use of the term "hypoallergenic gl ove" ... latex gloves, and continue ... Latex products are generally produced by a dipping process. Forms

Beta Healthcare Products Pvt. Ltd. - Food and Drug ...

Jan 08, 2018·Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K172942 Device Name Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 μg/dm² or less per glove of extractable protein)

Latex Glove - The World's Largest Manufacturer of Gloves

LATEX GLOVE FOR FOOD HANDLING. Latex Disposable Glove is a disposable device intended for food handling to prevent chemical substances migrating from the food contact material to the food and also to protect food from changes in taste or odor. European Countries: Meet Regulation (EC) No. 1935/2004; More Details Download Brochure Send Enquiry

Ansell Healthcare Products, LLC. 2301 Robb Drive ...

FORM FDA 3881 (7/17) Page 1 of 2 PSC Publishing Services(301) EF443-6740 510(k) Number (if known) . K190018 . Device Name . Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs

Turkish Medical Gloves Suppliers, Manufacturers ...

Nitrile Gloves: Superieur, Kimberly Clark (100 pcs) Hartalega Paloma (200), Cranberry Evolve (300) brands of Nitrile Powder Free Gloves. CIF Prices for Nitrile gloves : CE-ISO-FDA 100 pcs box of gloves : 9.40 USD 200 pcs box of gloves : 16.60 USD 300 pcs box of gloves: 24.80 USD Minimum Order Quantity is 5m Box Delivery CIF by Sea- in 22-25 days after SPA and Escrow Payment CIF/ Escrow …