Quality Latex Products Malaysia Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Quality Latex Products Malaysia 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: 9617445
• FEI Number: 3860
• Name: QUALITY LATEX PRODUCTS MALAYSIA SDN BHD
• Owner & Operator: Quality Latex Products Malaysia Sdn. Bhd.
• Contact Address: 18 & 20, Jalan Kilang 2, Jelapang Light Industrial Estate; Ipoh, Perak MY-08 Perak 30100 MY
• US Agent:
  • William Slevin
  • Medapproval LLC
  • 864 7352466
  • qara@medapprovalllc.com
• Importing Logistics Registration:
  • Importer: Pro2 Solution, Inc.
  • Address: 828 San Pablo Avenue ; Pinole, CA 94564 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 18 & 20, JALAN KILANG 2 JELAPANG LIGHT INDUST. ESTATE; IPOH Perak, 30100 MY
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K993271 | LYY QUALITY LATEX PRODUCTS MALAYSIA SDN BHD [Quality Latex Products Malaysia Sdn. Bhd.]	Examination Gloves	2008-07-09
PMN K893075 | LYY QUALITY LATEX PRODUCTS MALAYSIA SDN BHD [Quality Latex Products Malaysia Sdn. Bhd.]	Examination Gloves	2008-07-09
PMN K011995 | LYY QUALITY LATEX PRODUCTS MALAYSIA SDN BHD [Quality Latex Products Malaysia Sdn. Bhd.]	Polymer Coated Latex Medical	2008-06-06
PMN K011995 | LYY QUALITY LATEX PRODUCTS MALAYSIA SDN BHD [Quality Latex Products Malaysia Sdn. Bhd.]	Examination Gloves	2008-06-06
PMN K011995 QUALITY LATEX PRODUCTS MALAYSIA SDN BHD	POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)	2001-07-31