Flexitech Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Flexitech Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005374243
• FEI Number: 3005374243
• Name: David Lim
• Owner & Operator: FLEXITECH SDN. BHD.
• Contact Address: LOT 124 & 126, JALAN LAPAN KOMPLEKS OLAK LEMPIT; BANTING MY-10 Selangor 42700 MY
• Official Correspondent:
  • SIOW CHUN MIN
  • 60-3-31491998-x
• US Agent:
  • David Lim
  • 626 9697838 108
  • 626 9697823
  • Limdavid33@Gmail.com
• Importing Logistics Registration:
  • Importer: CARDINAL HEALTH 200, LLC
  • Address: 1430 WAUKEGAN ROAD ; Waukegan, IL 60085 UNITED STATES
• Importing Logistics Registration:
  • Importer: TG MEDICAL (USA), INC
  • Address: 165 NORTH ASPEN AVE. ; Azusa, CA 91702 UNITED STATES
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: TG MEDICAL (USA), INC.
  • Address: 165 NORTH ASPEN AVE ; Azusa, CA 91702 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 165 N. Aspan Ave ; Azusa, CA 91702 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K994416 FLEXITECH SDN. BHD.	POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE	2000-02-03
PMN K994354 FLEXITECH SDN. BHD.	POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)	2000-01-31
PMN K990502 FLEXITECH SDN. BHD.	PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)	1999-04-02
PMN K990501 FLEXITECH SDN. BHD.	POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM	1999-04-02
PMN K990499 FLEXITECH SDN. BHD.	PREPOWDERED NITRILE EXAMINATION GLOVES	1999-04-02
PMN K990495 FLEXITECH SDN. BHD.	POWDER FREE NITRILE EXAMINATION GLOVES	1999-04-02

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092938495	Port Swettenham,Malaysia -> Savannah, Georgia	2656 CASES OF NITIRILE GLOVES (NON MEDICAL GL .	2656 CAS
2020092914789	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	RUBBER GLOVE	2808 CAS
2020092514179	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	RUBBER GLOVE	2808 CAS
2020092112979	Port Swettenham,Malaysia -> Norfolk, Virginia	2458 CASES OF PI NO 2000116408 PO NO P11354 AL PURPOSE)	2458 CAS
2020091822848	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	NITRILE EXAMINATION GLOVE	2750 CAS
202009172495	Yantian,China (Mainland) -> Oakland, California	3000 CASES PI NO: 2000116275 PO NO: OGI-3 USA NITRILE GLOVE (NON MEDICAL) HS CODE: 4015-19 -1010 NO SOLID PACKING MATERIAL COUNTRY OF OR IGIN: MALAYSIA	3000 CAS
2020091658160	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	2656 CASES OF NITIRILE GLOVES (NON MEDICAL GL .	2656 CAS
2020091122514	Singapore,Singapore -> Long Beach, California	TOTAL:3200 CASES PI NO: 2000116504 LATEX AND NITRILE GLOVE ? NON MEDICAL PO NO : 1981075 HS CODE: 4015-19-1010 COUNTRY OF ORIGIN: MALAYSIA	3200 CAS