Kanghua Medical Products Co L T D

FDA Filings

This page includes the latest FDA filings for Kanghua Medical Products Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010968343
• FEI Number: 3010968343
• Name: KANGHUA MEDICAL PRODUCTS CO., LTD.
• Owner & Operator: SHEN WEI (USA), INC.
• Contact Address: 33278 CENTRAL AVE., SUITE 102; Union City CA 94587 US
• Official Correspondent:
  • BELLE - CHOU
  • x-510-4298692-x
• US Agent:
  • BELLE-CHOU
  • SHEN WEI (USA), INC.
  • 510 4298692
  • 510 4875347
  • CREEP@SWSAFETY.COM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: YANJIANG TECHNOLOGY PARK ; YANGZHONG CITY Jiangsu, 212213 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K190466 | QDO KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	APEXPRO	2020-03-30
PMN K190466 | LZC KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	APEXPRO	2020-03-30
PMN K190466 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	APEXPRO	2020-03-30
PMN K172678 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	TPE	2018-07-13
PMN K162312 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	BIODEGRADABLE NITRILE EXAM GLOVE WITH ALOE VERA	2017-08-03
PMN K170290 | LZC KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	PF Nitrile Exam Glove with pH Coating White-Black Color	2017-06-01
PMN K170290 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	PF Nitrile Exam Glove with pH Coating White-Black Color	2017-06-01
KPY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Sleeve, Latex Sterile exam Radiation	2014-05-15
KPY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Radiation Attenuation Sleeve Latex Exam	2014-05-15
PMN K972090 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES	2013-12-30
PMN K964628 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	NITRILE POWDER-FREE EXAMINATION GLOVES	2013-12-30
PMN K892742 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	PATIENT EXAMINATION GLOVES (LATEX)	2013-12-30
PMN K062067 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES NATURAL COLOR	2013-12-30
PMN K022220 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS GREEN COLOR	2013-12-30
PMN K013795 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	LATEX GLOVES	2013-12-30
PMN K013794 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	LATEX GLOVES	2013-12-30
PMN K013793 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS	2013-12-30
PMN K011961 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE VITAMINS E PH5.5	2013-12-30
PMN K011045 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM	2013-12-30
PMN K121811 | LZC KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Radiation Attenuation Latex Gloves	2013-01-15
PMN K121528 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Nitrile Gloves	2012-12-17
PMN K120890 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Nitrile Gloves	2012-12-17
PMN K120890 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Global Glove 775PF	2012-12-17
PMN K120890 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Global Glove 675PF	2012-12-17
PMN K113233 | KGO KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Latex Surgeon Gloves	2012-04-03
PMN K101436 | LZC KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	nitrile gloves	2010-12-17
PMN K101436 | LZC KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Latex Gloves	2010-12-17
PMN K101436 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	nitrile gloves	2010-12-17
PMN K101436 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Latex Gloves	2010-12-17
PMN K100211 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Latex Gloves	2010-05-14
PMN K092411 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	nitrile gloves	2010-04-09
PMN K092411 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Latex Gloves	2010-04-09
PMN K033539 | LYZ KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Vinyl Gloves	2010-04-09
PMN K032084 | LYZ KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	DISPOSABLE VINYL EXAMINATION GLOVES; PATIENT VINYL EXAMINATION GLOVES	2010-01-29
PMN K032024 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Nitrile Gloves	2010-01-29
PMN K032024 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Latex Gloves	2010-01-29
PMN K090194 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	NITRILE EXAM GLOVES	2009-09-02
PMN K051683 | LYZ KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	DISPOSABLE VINYL EXAMINATION GLOVES; PATIENT VINYL EXAMINATION GLOVES	2009-09-02
PMN K062919 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Powder Free Nitrile Exam	2007-12-12
PMN K060073 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	POWDER FREE NITRILE	2007-12-03
PMN K050467 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	POWDER FREE BUTADIENE	2007-12-03
PMN K033692 | LYZ KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	POWDERED VINYL	2007-12-03
PMN K030583 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	LATEX POWDER FREE	2007-12-03
PMN K011044 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Latex Gloves	2007-12-03
PMN K010110 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	POWDER FREE NITRILE	2007-12-03
PMN K010097 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	NITRILE EXAM GLOVES	2007-12-03
PMN K993876 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	nitrile gloves	2007-11-30
PMN K993876 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Latex Gloves	2007-11-30
PMN K992200 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Latex Gloves	2007-11-30
PMN K991422 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	nitrile gloves	2007-11-30
PMN K991422 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Latex Gloves	2007-11-30
PMN K983145 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	POWDER FREE LATEX	2007-11-30
PMN K955029 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Latex Gloves	2007-11-30
EFW KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	TOOTHBRUSH	2006-07-19
PMN K061756 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	NITRILE EXAM GLOVES	2006-07-17
PMN K061756 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	LATEX EXAM GLOVES	2006-07-17
PMN K061756 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	NITRILE EXAM GLOVES	2006-07-17
PMN K061756 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	LATEX EXAM GLOVES	2006-07-17
PMN K033693 | LYZ KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	PATIENT VINYL EXAMINATION GLOVES	2005-12-16
PMN K033693 | LYZ KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	DISPOSABLE VINYL EXAMINATION GLOVES	2005-12-16
PMN K962461 | LZA KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	POWDER-FREE NITRILE EXAM GLOVES	2005-11-14
PMN K935812 | LYY KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	POWDER-FREE LATEX EXAM GLOVES	2005-11-14
BTC KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Non-Latex Breathing bag	2005-02-08
BTC KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	Latex Breathing bag	2005-02-08
GBW KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	PENROSE DRAIN	2004-12-21
GAX KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	NON-LATEX TOURNIQUET	2004-03-23
GAX KANGHUA MEDICAL PRODUCTS CO., LTD. [SHEN WEI (USA), INC.]	LATEX TOURNIQUET	2004-03-23

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018082157895	Shanghai ,China (Mainland) -> Seattle, Washington	8MIL 11 BLUE NITRILE EXAM GLOVE 8 MIL INDUST RIAL FLOCKLINED BLACK NITRILE 5.5 MIL ORANGE NITRILE WITH ALOE AND COLOR-Q PO.4003093/40 03292 WE CERTIFY THAT THERE IS NO SOLID WOO D PACKING IN THIS SHIPMENT	2230 CTN
2018060450636	Shanghai ,China (Mainland) -> Seattle, Washington	8MIL 11 BLUE NITRILE EXAM GLOVE AS PER PO#40 02874	1600 CTN
2018022112802	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	WWMP GLOVE EXAM NITRILE PF TEXTURE(BLUE) WWMP LATEX EXAM GLOVE PF TEXTURE PO.JE039870 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS	1105 PKG
2018012712123	Shanghai ,China (Mainland) -> Oakland, California	BL EXAM NITRILE GLOVES PFTEXTURE	2040 PCS
2018012746518	Shanghai ,China (Mainland) -> Oakland, California	BL EXAM NITRILE GLOVES PFTEXTURE PO.013457	1800 PCS
2018012616111	Shanghai ,China (Mainland) -> Oakland, California	BL EXAM NITRILE GLOVES PFTEXTURE	2040 PCS
2018012662338	Shanghai ,China (Mainland) -> Oakland, California	BL EXAM NITRILE GLOVES PFTEXTURE PO.013457	1800 PCS
2018012031247	Shanghai ,China (Mainland) -> Oakland, California	BL EXAM NITRILE GLOVES PFTEXTURE	2040 PCS