hartalega nitrile gloves fda certification

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hartalega nitrile gloves fda certification

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.

Hartalega - Potential FDA approval on AMG Antimicrobial ...- hartalega nitrile gloves fda certification ,Jun 24, 2020·Hartalega's AMG Antimicrobial gloves is expected to obtain FDA approval before end of the year. AMG Antimicrobial gloves is Hartalega's invention and Hartalega is the only company in the world that is able to mass produce this gloves. It kills 99.99% of bacteria transmission that every other gloves would not be able to.Nurul Kong Quality Assurance Senior Manager Regulation ...www.fda.gov Hartalega Sdn. Bhd. Nurul Kong Quality Assurance Senior Manager No. 7, Kawasan Perusahaan Suria Bestari Jaya, 45600 My Re: K180505 Trade/Device Name: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)



Medical Gloves for COVID-19 | FDA

Answers to frequently asked questions about medical gloves, including manufacturing, purchasing, importing, and donating gloves during the COVID-19 public health emergency.

Hartalega SDN. BHD. - Food and Drug Administration

The gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Carmustine (3.3 mg/ml) Cisplatin (1.0 mg/ml) Cyclophosphamide (20.0 mg/ml)

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

Hartalega Paloma, Paloma Nitrile Glove, Hartalega Gloveon Paloma manufacturer / supplier in China, offering Hartalega Paloma FDA 510K, Silicone Epaulettes with Embossed Logo, Powder Free Nitrile Gloves (100PCS) and so on.

510(k) Premarket Notification - Food and Drug Administration

Feb 08, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K200581: Device Name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

Denmark Hartalega Gloves - Medical Gloves - Nitrile Gloves

Hartalega Gloves Details. This disposable nitrile gloves has higher abrasion resistance and better heat resistance. It is made of high-quality nitrile rubber with other additives, refined and processed; it does not contain protein, has no allergic reaction to human skin, is …

China Gloveon Paloma - Nitrile Exam - Powder Free - FDA ...

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.

Hartalega Paloma Nitrile Gloves by PPE Company. Supplier ...

Hartalega PALOMA (Box of 200 pcs) Nitrile Powder free glove with CE FDA MOQ at 5 mil boxes Lead time 4-5 weeks Delivery : FOB Payment term : Irrevocable Transferable LC SOP : Buyer : LOI and BCL (valid within 1 week) Seller : FCO Buyer : ICPO Seller : SPA Buyer : Ready LC Seller : Production Buyer : Arrange SGS inspection Seller : Delivery goods and all documents include certificates, reports..

Hartalega Paloma Nitrile Gloves by PPE Company. Supplier ...

Hartalega PALOMA (Box of 200 pcs) Nitrile Powder free glove with CE FDA MOQ at 5 mil boxes Lead time 4-5 weeks Delivery : FOB Payment term : Irrevocable Transferable LC SOP : Buyer : LOI and BCL (valid within 1 week) Seller : FCO Buyer : ICPO Seller : SPA Buyer : Ready LC Seller : Production Buyer : Arrange SGS inspection Seller : Delivery goods and all documents include certificates, reports..

Denmark Hartalega Gloves - Medical Gloves - Nitrile Gloves

Hartalega Gloves Details. This disposable nitrile gloves has higher abrasion resistance and better heat resistance. It is made of high-quality nitrile rubber with other additives, refined and processed; it does not contain protein, has no allergic reaction to human skin, is …

510(k) Premarket Notification - accessdata.fda.gov

Feb 01, 2021·NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS ... HARTALEGA SDN BHD: NO. 7, KAWASAN PERUSAHAAN: SURIA: bestari jaya, MY 45600 Applicant Contact: nurul aisyah kong bt abdullah: Correspondent: HARTALEGA SDN BHD ... MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. For Government; For …

Hartalega Sdn Bhd | Medical Manufacturer Directory

Hartalega is the leading gloves manufacturer specialize in premium grade nitrile and latex gloves for medical, dental, laboratory, food and semiconductor markets since 1988. Well-known for our legacy in innovations, Hartalega is the first to develop soft, lightweight nitrile gloves which initiated a global demand shift from latex to nitrile gloves.

Hartalega Products - MED GEAR USA - Saving lives by ...

Gloveon Coats Nitrile Gloves Hartalega Specification Certificate - CE, FDA Thickness Palm - 0.07~0.09mm Finger - 0.09~0.11mm Color Dawn Blue, White Made in Malaysia

China Hartalega Gloveon Paloma Box 200 - China Hartalega ...

Hartalega Paloma Pdf, Hartalega Paloma Specification Pdf, Hartalega Paloma Box Size manufacturer / supplier in China, offering Hartalega Gloveon Paloma Box 200, Vaccine Syringes Pump Use Syringe Beer Pump Cookies Mold Automatic Vaccine Syringes, Cranberry Evolve 300 OTG USA and so on.

Industrial - Hartalega

With our range of gloves, you can work in complete confidence even in hazardous or high-risk environments such as those in electrical, mechanical or chemical industries. Our products have strong barrier strength paired with high elasticity to keep you protected without restricting your movement. For those involved in enforcement work, drug handling as well as industries such as pharmaceutical ...

Nitrile Gloves – Global Gain Enterprises

Nitrile gloves 100 pieces / box FDA HS certificates 40151900. EC, KCS, EN388, EN511, EN374-1, EN420, EN407, EN374-5, ANSI ... HARTALEGA NITRILE GLOVES · Gloveon STOCK AVAILABLE IN MALAYSIA ... BESTSAFE NITRILE GLOVES. PRODUCTION: THAILAND.

Hartalega Gloveon Paloma Nitrile Gloves by Ovoc Pte. Ltd ...

Latex Examination Gloves Nitrile Disposable Gloves * Hartalega Paloma FOB Malaysia. 50 million boxes monthly* - made in Malaysia with CE and FDA certification - export quality gloves - from local manufacturer Ruberrex, Hartalega Paloma, Kossan, , Supermax, Kimberly Clark, YTY etc - powder free - packing by weight - Pp polybag packing ...

Hartalega Sdn Bhd | Medical Manufacturer Directory

Hartalega is the leading gloves manufacturer specialize in premium grade nitrile and latex gloves for medical, dental, laboratory, food and semiconductor markets since 1988. Well-known for our legacy in innovations, Hartalega is the first to develop soft, lightweight nitrile gloves which initiated a global demand shift from latex to nitrile gloves.

How to Import Nitrile Gloves | USA Customs Clearance

Mar 27, 2020·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. It's important to note that many nitrile gloves have already ...

Hartalega Paloma Nitrile Powder Free Examination Gloves ...

Buy Hartalega Paloma Nitrile Powder Free Examination Gloves Certifications: Fda 510K at Price 8.4 USD/Box in Bangkok 10250 Thailand., Bangkok. Hartalega Paloma Nitrile Powder Free Examination Gloves offered by __COMPANY_NAME __ is available with Color, Product Type and trade infomation.

Nitrile Powder Free 3.5 Mil - Hartalega

A strong and durable glove that is a pleasure to don with its elastic properties. It has been tested for a wide range of chemicals. ... FDA 510(k), MDR 2017/745, REACH, ROHS Directive 2002/95/EC, EC 10/2011, EC 1935/2004, PPER 2016/425. ... By engaging or communicating with Hartalega Holdings Berhad (“Company”) for the purposes of applying ...

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

Hartalega Paloma, Paloma Nitrile Glove, Hartalega Gloveon Paloma manufacturer / supplier in China, offering Hartalega Paloma FDA 510 K, Vaccine Syringes Pump Use Syringe Beer Pump Cookies Mold Automatic Vaccine Syringes, Cranberry Evolve 300 OTG USA and so on.

Hartalega Powder-Free Nitrile Exam Gloves | MQ Direct

Our Hartalega Matig gloves are reliable, FDA approved and come in a variety of sizes. Explore powder-free nitrile exam gloves at MQ Direct. Our Hartalega Matig gloves are reliable, FDA approved and come in a variety of sizes. Your exclusive offer: take 20% off sitewide.

Hartalega SDN. BHD. - Food and Drug Administration

The gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Carmustine (3.3 mg/ml) Cisplatin (1.0 mg/ml) Cyclophosphamide (20.0 mg/ml)

Certifications - Hartalega

Hartalega NGC SdnBhd No. 1, PersiaranTanjung, KawasanPerindustrianTanjung, 43900 Sepang, Selangor Email: [[email protected]] Phone: [03-8707 3000] Notwithstanding the withdrawal of your consent, the Company may still proceed to process your Personal Data and/or Sensitive Personal Data in circumstances recognised and permitted by law.