malaysia nitrile gloves 510k pdf instructions

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VGLOVES - ANV IMPORT EXPORT- malaysia nitrile gloves 510k pdf instructions ,Synthetic Nitrile latex. Type: Non-Sterile Powder-Free. Ambidextrous; Finger Tip Textured; Beaded Cuff; White or Coloured (Blue, Light Blue, …) Quality Standards: Conforms to ASTM D6319 Manufactured under ISO9001: 2008, ISO 13485:2003. ISO 22000:2005 Quality Management System. Manufactured from 100% nitrile (Acrylonitrile-Butadiene) Gloves Size510(k) Summary Latex Examination Gloves Powder Free 1.0 ...510(k) Summary Latex Examination Gloves Powder Free 1.0 Submitter:JU1G20 Company Name: Riverstone Resources Sdn. Bhd. Company Address: Lot 55, 56, No. 15 Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung Selangor, Malaysia. Contact Person: Ms. Chong Chu Mee Telephone No: +603-60283033 Fax No: + 603-60283022



Latex Nitrile Medical Examination, Glove Malaysia - EC21

GloveMalaysia - Malaysia supplier of Latex Nitrile Medical Examination, Glove Malaysia

Blog | Nitrile Glove Supply From Asia

Aiif Gloves Nitrile Gloves Specification & Offer (2020.12.19) Aiif gloves nitrile gloves made in Thailand lead time 30〜45days for first shipping. FDA 510k CE have it MOQ 100,000box〜 quapacity 10,000,000box T/T contract and pay direct to factory you can order 100,000boxes at 6.9usd(SML size, 100pcs) an 7.1usd(XL, 90pcs) L/C100% contract and ...

Malaysian Gloves Fda Manufacturers | Suppliers of ...

...nitrile industrial gloves non medical use 16 packages sample pack commodity code (h. s. code): 4015. 19. 0000 #006292 made in malaysia fda (510k)usa...

(Malaysia) AGRO SDN BHD (Malaysia) TOP CARE SDN BHD (Malaysia) FOUNDATION* (Malaysia) GMP MEDICARE SDN BHD (Malaysia) TOP QUALITY GLOVE SDN BHD (Malaysia) TG MEDICAL (USA) INC. ( Listed on Main Market of Bursa Malaysia ) CORPORATION BERHAD 100% 100% 100% 100% 36.84% 97.5% 100% 100% 100% 100% 27% …

Tests required for latex and nitrile gloves for FDA 510K ...

US FDA Medical Device Labeling Requirements - Gloves. Contents of examination and surgical gloves (Latex / Nitrile) 510k Notification. US FDA 510K Submission Format. FDA publish all 510k clearance on fda website, you can find substantial equivalence letter at www.fda.gov. Below are examples of examination and surgical glove 510k clearance letter

FDA 510k qualified Nitrile Exam Gloves ready to go in ...

FDA 510k qualified Nitrile Exam Gloves ready to go in Malaysia. Close • Posted by 1 hour ago. FDA 510k qualified Nitrile Exam Gloves ready to go in Malaysia. Email us if you are interested - [email protected] 0 comments. share. save. hide. report. ... NEED medical grade 4mil nitrile…

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

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

Nitrile Gloves company list in Malaysia

Safety Gloves, work gloves, PU gloves, nitrile gloves, coated gloves, knitted gloves, nylon glove, cut resistant glove, ESD glove, anti-static glove, dyneema Unigloves Berhad Lot 18374, Jalan Perusahaan 3,Kamunting Industrial Estate, Kamunting, Perak Darul Ridzuan

Tests required for latex and nitrile gloves for FDA 510K ...

US FDA Medical Device Labeling Requirements - Gloves. Contents of examination and surgical gloves (Latex / Nitrile) 510k Notification. US FDA 510K Submission Format. FDA publish all 510k clearance on fda website, you can find substantial equivalence letter at www.fda.gov. Below are examples of examination and surgical glove 510k clearance letter

Disposable Glove, Vinyl Glove, PVC Glov, PE Glove - Hongray

Shijiazhuang Hongray Group is the largest manufacturer of disposable protective gloves in the world. Our group has five major production bases in Shijiazhuang, Jinzhou, Xinji, Zanhuang, Shenze of Hebei Province. We produce various vinyl gloves, nitrile gloves, PE and non-woven series products with the annual output of 14 billion pieces of gloves.

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.

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.

Disposable Nitrile | Ace Glove Sdn. Bhd.

Brief Intro. ACE GLOVE (M) SDN BHD is one of the leading supplier or exporter in Malaysia offering largest range of gloves such as Latex Examination Gloves, Nitrile Examination Gloves, Surgical Gloves, Household Gloves and other latex products. Our alliance with major latex and nitrile glove manufacturer provided us the competitive advantage to fulfill and satisfy customer requirement.

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.

Product Information

Product Superieur Nitrile Gloves FDA 510k and CE Certified Gloves Place of manufacture Thailand, Malaysia and Vietnam Configuration 100 gloves per box Size by % S, M, L, XL Thickness See spec sheets for specifics Color Blue Total Quantity TBD Delivery frequency TBD Term TBD Commencing TBD Shipping CIF Sea included.

Fact Sheet: Disposable Nitrile Gloves in Chemical Labs ...

Nitrile is a synthetic rubber material that offers chemical and abrasion resistance and is a very good general-duty material for gloves. Thin, disposable, nitrile gloves are the most common gloves used when handling chemicals in laboratories; however, it is important to remember that thin nitrile rubber provides only limited chemical protection.

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.

Guide to Chemical-Resistant Best Gloves

Glove Families: Gloves Tested for this Guide reflect a cross-section of products produced by Best Glove Inc. Other products in the same product family will have similar chemical resistance properties. N-DEX 6005 exam glove is equivalent to N-DEX 7005 listed. Nitri-Solve 730, 737 and 747 are at …

Examination glove standards and Malaysian product ...

• Malaysia is the world’s leading exporter of medical gloves • The many standards that are applicable lead to higher cost to both Malaysian producers and importers/users of Malaysian gloves • SMG examination gloves are certified for compliance with the EN, ASTM and ISO standards

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.

Halyard Health Christine Macauley Regulatory Affairs ...

510(k) Summary (K180646) Page 2 of 5 Indications for Use The Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and

Industrial Gloves Manufacturer Malaysia | Latex ...

COMPANY CORPORATE PROFILE. HANG FU TRADING is a subsidiary of HANG FU RUBBER INDUSTRIES SDN BHD. One of the Leading Gloves supplier, exporter and contract manufacturer company for LATEX EXAMINATION GLOVES, NITRILE EXAMINATION GLOVES, SURGICAL GLOVE, HOUSEHOLD GLOVE and INDUSTRIAL GLOVES.It has been established since 1991 in Malaysia.

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ...

Sep 05, 2014·(510k#: K141623) Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999 510(K) Summary EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs 1.0 Submitter : Company Name : ECO MEDI GLOVE SDN. BHD.

COATS® Nitrile | Gloveon

Nitrile, Powder Free, Standard Cuff, Non-Sterile, Fingertip Textured. Made from 100% all natural oats, COATS ® is a patented glove coating technology recognized by the FDA as a skin protectant. Colour – Dawn Blue: Material – Synthetic Nitrile Rubber: Product Conformance – ASTM D6319: Packing Method – 100 gloves per box 10 boxes per ...