Hartalega fda approved. November 2, 2018 Hartalega Sdn.

Hartalega fda approved The company specializes in the production of a range of gloves, including specialty gloves with features such as antimicrobial, colloidal oatmeal coated, accelerator-free, and biodegradable options. The glove has been tested safe for food contact according to the standards of U. Nurual Kong Quality Assurance Senior Manager No. , known as “novel” drugs. Nurul Aisyah Kong General Manager - Quality Assurance No. Ultimately, AMG antimicrobial glove helps reduce the risk of transmission from an Apr 4, 2019 · The financial analyst company argued that the acceptance rate of the product is still low as it has yet to receive the approval of the US Food and Drug Administration (FDA). , Oct. 99% of bacteria transmission that every other gloves would not be able to. HARTALEGA NGC SDN. AMG glove helps to prevent Healthcare-Associated Infections (HAI) with test data proven kill up to 99. 2600, BfR XXI German Recommendation and Japan Food Sanitation on various types of simulants representing different types of food that are acidic, alcoholic and fatty in content. 6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: July 16, 2018 Received: July 23, 2018 The cover visual and theme of this year's report, "Pushing Forward", embody Hartalega's resilience and optimism in navigating the challenging market landscape. See Drugs@FDA for information about all of CDER’s approved drugs and biological products. Therefore, I cannot extract BDGTM Nitrile Biodegradable Gloves are an eco-friendly option for use in medical, laboratory, food and industrial fields. Oct 8, 2022 · ShieldOn gloves are FDA-approved and suitable for dental, medical, food, beauty, janitorial, and industrial use. The coating also functions as a barrier between glove and skin, preventing skin irritation from prolonged glove film contact. It also details Hartalega 510 (k) Premarket NotificationFDA Home Medical Devices Databases 1 day ago · Up to date information on the latest FDA drug approvals. United Global Trading Corp. D. Although this letter refers to your p Searchable database of FDA 510 (k) applications and descisions. COATS® gloves are a clinically proven solution for anyone who suffers from dry and irritated skin due to prolonged glove use and frequent hand washing. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung Sepang, Selangor Darul Ehsan 43900 Malaysia Hartalega created the world's first colloidal oatmeal coated gloves - COATS®. Hartalega BDGTM Nitrile Biodegradable Gloves The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Powder Free Sterile Latex Surgical Gloves, Contains 50 Microgram Or Less Of Total Water Extractable Protein Per Gram. 19551007775623 Nitrile examination/treatment glove, non-powdered, non-antimicrobial August 4, 2016 Hartalega Sdn Bhd Nurul Kong Quality Assurance Senior Manager No. regarding the substantial equivalence of their "Green Chlorinated Powder Free Latex Examination Gloves (With Protein Labeling Claim)". c/o Nurul Kong Quality Assurance Senior Manager Hartalega SDN. Hartalega NGC Sdn. Equipped with Hartalega's revolutionary biodegradable technology, this glove also features the FDA-recognised, clinically proven skin protectant made from 100% natural colloidal oatmeal of the COATS® glove. For more information on the Orange Book update frequency, see the Orange Book FAQs. Demand attracted new suppliers, flooding the market with lower-quality gloves, but at inflated prices. It indirectly produces clean and renewable energy through the unique and organic additive that attracts microbes commonly found in landfills to disintegrate the gloves naturally, leaving behind only biogas, water and inert soil. A list of members of the FDA Center for Drug Evaluation and Research (CDER) Exclusivity Board who made the decision to block the approval of BRIXADI because of unexpired three year exclusivity for Please send general questions related to the drug data in these files to the Center for Drug Evaluation and Research, Division of Drug Information: druginfo@fda. Nurul Kong Quality Assurance Senior Manager C-G-9 Jalan Dataran SD1 Dataran SD PJU 9 Bandar SRI Damansara, 52200 MY. It is a regulatory approval document and not a scientific study report. September 26, 2019 Hartalega Ngc Sdn. Nurul Kong Senior Manager- Quality Assurance Kawasan Perindustrian Tanjung Sepang, Selangor 43900 Ma laysia Re: K2005Sl Trade/Device Name: Paloma Nitrile powder Free Examination Gloves (Blue) Regulation Number: 21 CFR 880. rdance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval applic tion (PMA). Hartalega's certifications ensure the highest standards of quality and meeting all requirements. You may, therefore, market he device, subject to the general controls provisions of the Act. (UGTC) announces a non-exclusive partnership with Hartalega to import, sell and distribute ShieldOn nitrile, powder-free examination gloves tested for use with XS-L: 100 Gloves XL: 90 Gloves By Weight TGA -ARTG 164563, FDA 510(k) EN 374 STERILE EN 374 M 91 L XL 101 109 Made in Malaysia by Hartalega Sdn Bhd. November 2, 2018 Hartalega Sdn. Mahalia Liyana Mat Harun Manager - Regulatory Affairs No. ShieldOn gloves are FDA-approved and suitable for dental, medical, food, beauty, janitorial, and industrial use. 2022 08h15 HE | Source: United Global Trading Corp. with the FDA for Latex Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove (natural), Latex Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove (gr. Oct 6, 2022 · FDA-Approved ShieldOn Precision Gloves Currently En Route to Los Angeles UGTC Logo UGTC Logo LONG BEACH, Calif. Jul 27, 2020 · The long awaited FDA approval for Hartalega AMG glove is finally here, just updated today on FDA website . Operating since 1988, we are known as the world's most innovative glove manufacturer that constantly delivers high-quality products A list of members of the FDA Center for Drug Evaluation and Research (CDER) Exclusivity Board who made the decision to block the approval of BRIXADI because of unexpired three year exclusivity for COATS ® bio Nitrile Powder Free COATS® Bio is an innovative green initiative prioritising both user well-being and a healthier environment. ℅ Nurul Kong Quality Assurance Senior Manager Hartalega Sdn. Feb 19, 2008 · The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. The theme reflects Hartalega's purposeful advancement Apr 17, 2008 · Hartalega Holdings is a manufacturer of nitrile gloves, serving various sectors within the healthcare and industrial domains. Includes list of most recent approvals, the conditions approved for, and the approval history. 3 days ago · 510 (k) Premarket NotificationFDA Home Medical Devices Databases June 1, 2020 Hartalega SDN. (UGTC) announces a non-exclusive partnership with Hartalega to import, sell and distribute ShieldOn nitrile, powder-free examination gloves tested for use with chemotherapy drugs and fentanyl, to meet the demands of the North American market. (UGTC) announces a non-exclusive partnership with Hartalega to import, sell and distribute ShieldON nitrile, powder-free examination gloves tested for use with chemotherapy drugs and fentanyl, to meet the demands of the North American market Hartalega NGC Sdn. reserved product code For Tina Kiang, Ph. FEATURES Fingertip textured Powder Free Not made with natural rubber latex Chemo drugs tested Lab chemical tested Ambidextrous Standard cuff Dawn blue colour COATS Colloidal Oatmeal System Nitrile Examination Glove Features a patented and unique glove technology. 7, Kawasan Perusahaan Suria Bestari Jaya, 45600 My Re: K180786 Trade/Device Name: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff Hartalega COATS Colloidal Oatmeal Coated Nitrile Powder Free 2. Let us read! The following data is part of a premarket notification filed by Hartalega Sdb. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations. The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Patient Examination Gloves. Oct 6, 2022 · FDA-Approved ShieldOn Precision Gloves Currently En Route to Los Angeles 06 oct. U. COATS® utilises the powerful benefits of all-natural oats, an FDA-recognised skin protectant, as a coating that forms a natural, moisturising barrier Director’s Message Welcome to FDA’s Center for Drug Evaluation and Research’s (CDER) 14th annual report, Advancing Health Through Innovation: New Drug Therapy Approvals. Although this letter refers to your product as a device, In June 2003, colloidal oatmeal has gained the FDA approval to be used as a skin protectant. You may, therefore, market th device, subject to the general controls provisions of the Act. Bhd No. Definition A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513 (i) (1) (A) FD&C Act) that is not subject to premarket approval. Hartalega Sdn Bhd FDA Filings This page includes the latest FDA filings for Hartalega Sdn Bhd. Oct 11, 2021 · We are pleased to offer our buyers Hartalega Kompassafe or OEM (Using the same spec as Coats) -Can print own packaging -FDA 510K approved Priced at only Hartalega 100 90 Gloves By Weight Made in Malaysia by Hartalega Sdn Bhd. 7, Kawasan Perusahaan Suria Bestari Jaya, 45600 My Re: K180644 Trade/Device Name: Nitrile Powder Free Examination Gloves with Colloidal Oatmeal -Lemon Green Regulation Number: 21 CFR 880. gov. During the COVID-19 pandemic, the global demand for single-use gloves skyrocketed and exceeded manufacturers' production capacity. COATS utilizes the powerful benefits of all natural oats, an FDA-recognized skin protectant, as a coating that forms natural moisturizing barrier between the glove and skin. 7, Kawasan Perusahaan Suria Bestari Jaya, 45600 My AMGTM Antimicrobial Glove is the world’s first non-leaching antimicrobial examination gloves, designed to kill microbes on the external side of the gloves quickly upon contact. 6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product l Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). It does not contain information about the acceptance criteria and study details as requested. 6250 Regulation Name: Paloma Powder Free Examination Glove Regulatory Class: Class I. Hartalega expects to secure the agency's approval for the distribution of AMG in the US market within the first half of 2019. FEATURES Fingertip textured • Powder Free Not made with natural rubber latex Chemo drugs tested Lab chemical tested Ambidextrous Standard cuff Dawn blue colour assoc xs s 72 80 Actual Dimension in millimetres (mm) HOW COATS@ GLOVE WORKS Normal Drug Approval Reports by Month Drugs@FDA Postmarket Drug Safety Information for Patients and Providers Prescription Drug User Fee Amendments Biological Products Jun 10, 2022 · ShieldOn gloves are FDA-approved and suitable for dental, medical, food, beauty, janitorial, and industrial use. Realising the unique benefits of colloidal oatmeal, HARTALEGA was able to combine this knowledge with its innovative glove making technology to offer COATS® – the revolutionary glove that goes beyond protection Searchable database of FDA 510 (k) applications and descisions. Jul 12, 2025 · Discover the top 10 safety gloves manufacturers offering ANSI-certified cut resistance, chemical protection, and ergonomic designs. Nov 3, 2025 · What are "Novel" Drugs? "Novel" drugs are new drugs never before approved or marketed in the U. The image of a team rowing through choppy waters symbolises our unified approach, with the rowers representing our dedicated Hartanians working together towards achieving our vision. This patented glove coating technology contains US FDA recognised skin protectant, which effectively protects and moisturises the skin. opulententerprises. Bhd. Hartalega share price would command a significant premium upon approval by Colloidal oatmeal has gained the FDA approval to be used as a skin protectant. Contact - sridhar@opulententerprises. It kills 99. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung Sepang, Selangor 43900 Malaysia FDA 510K Powder Free Nitrile Examination Gloves Evolve 300 FDA 510K Powder Free Nitrile Examination Gloves COATS 100 Brand/Model: Hartalega COATS 100 FDA 510K Approved Standard: Complies with EN 455 and EN 374; ASTM D6319 (USA Related Product) Main material: Latex-free Powder-free Synthetic nitrile rubber September 24, 2022 Hartalega NGC SDN BHD Nurul Kong Deputy General Manager - Quality Assurance NO. Unlike traditional gloves, COATS® uses a unique and patented glove-coating technology that incorporates all-natural oats, a recognised skin protectant approved by the FDA. AMG Antimicrobial gloves is Hartalega's invention and Hartalega is the only company in the world that is able to mass produce this gloves. FDA. 7, Kawasan Perusahaan Suria Bestari Jaya, 45600 MY Re: K160560 Trade/Device Name: Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim And Tested For Use With Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880. Jul 14, 2025 · FDA Novel Drug Therapy Approvals for 2024: FDA Novel Drug Therapy Approvals for 2024 In 2024, CDER approved 50 new drugs never before approved or marketed in the U. Although this letter refers to your product as a device, please be aware that some cleared produ The provided text is a letter from the FDA to Hartalega Sdn. Hartalega Ngc Sdn Bhd FDA Filings This page includes the latest FDA filings for Hartalega Ngc Sdn Bhd. Current through November 2025. com www. com Colloidal Oatmeal System Nitrile Exam Gloves Powder Free, Standard Cuff COATS® (an acronym for colloidal oatmeal system) is a patented and unique nitrile glove technology. 5 Mil COATS (an acronym for colloidal oatmeal system) is a patented and unique nitrile glove technology. Oct 6, 2022 · ShieldOn gloves are FDA-approved and suitable for dental, medical, food, beauty, janitorial, and industrial use. Tomorrow Hartalega up 15%-20% to at least RM21Device Antimicrobial Medical GloveRegulation Description Non-powdered patient examination glove. report GUDID HARTALEGA NGC SDN. 510 (k) Premarket NotificationFDA Home Medical Devices Databases K200019 - Nurul Kong Page 2 Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. S. The Colloidal Oatmeal Coated Latex gloves offer a soft and stretchy material that conforms to the shape of your hand for superior comfort and dexterity. Hartalega Sdn Bhd Nurul Kong Quality Assurance Senior Manager No. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. BHD. Partners With Hartalega to Supply North America With Nitrile Examination Gloves Long Beach, CA – United Global Trading Corp. FOOD & DRUG ADMINISTRATION April 25, 2020 Hartalega NGC BHD. The approval process is lengthened given that the FDA views AMGs as a new product category. We expect contributions from AMGs to be miniscule for FY20 before pace picks up post FDA approval expected in the latter part of FDA approved the first generic referencing Victoza (liraglutide injection) 18 mg/3 mL, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and November 6, 2017 Hartalega NGC SDN. 06, 2022 (GLOBE NEWSWIRE) -- United Global Trading Corp. A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513 (i) (1) (A) FD&C Act) that is not subject to premarket approval. 510 (k) Premarket NotificationFDA Home Medical Devices Databases Hartalega Holdings Berhad's Integrated Annual Report 2024, themed 'Pushing Forward', highlights the company's resilience and teamwork in overcoming market challenges while focusing on sustained growth. 7, Kawasan Perusahaan Suria Bestari Jaya, Selangor 45600 Malaysia We are pleased to offer our buyers Hartalega Kompassafe or OEM (Using the same spec as Coats) -Can print own packaging -FDA 510K approved Priced at only Dear Nurul Kong: not require approval of a premarket approval application (PMA). Although this letter refers to your product as a device, please be aware United Global Trading Corp. 1 Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang, Selangor Darul Ehsan 43900 Malaysia United Global Trading Corp. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the We would like to show you a description here but the site won’t allow us. (UGTC) announces a Sep 24, 2025 · Novel Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products Drug and Biologic Approval and IND Activity Reports This Week's Drug Approvals Drug Trials Snapshots Oct 6, 2022 · United Global Trading Corp. Oct 6, 2022 · United Global Trading Corp. FDA 21 CFR 177. You may, therefore, market the device, subject to the general controls provisions of the Act. Dear Nurul Kong: ug, and Cosmetic Act (Act) that do not require approval of a premarket approval application ( MA). This acts as a preventive measure against skin Apr 19, 2019 · We understand that Hartalega’s antimicrobial gloves (AMGs) are still awaiting Food and Drug Administration (FDA) approval. 2013 2013 Jul 10, 2020 · Hartalega's AMG Antimicrobial gloves is expected to obtain FDA approval before end of the year. Drugs@FDA allows you to search for official information about FDA approved innovator (brand name) and generic drugs and therapeutic biological products. NHD NO. FDA Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. 999% of selected microbes. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. hhs. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2020 A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513 (i) (1) (A) FD&C Act) that is not subject to premarket approval. Learn more A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513 (i) (1) (A) FD&C Act) that is not subject to premarket approval. The report outlines the company's strategic objectives, operational and financial performance, and commitment to Environmental, Social, and Governance (ESG) practices. nxjcnza xptbk eurkgu afoq yixj wnjy umnpm mdtcd blcgn xvsq zkecy lhyesf blkpn uzqjfwf oxxbwo