TPLC - Total Product Life Cycle

• Device: polymer patient examination glove
• Regulation Description: Patient examination glove.
• Definition: A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
• Product Code: LZA
• Regulation Number: 880.6250
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANSELL HEALTHCARE PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	7
BARRIERMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
BRIGHT ELEMENT SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
BRIGHTWAY HOLDINGS SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	7
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	5
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	3
DYNAREX
	SUBSTANTIALLY EQUIVALENT	1
ETHICON
	SUBSTANTIALLY EQUIVALENT	1
FLEXITECH SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
GLOVCO
	SUBSTANTIALLY EQUIVALENT	3
GRAND
	SUBSTANTIALLY EQUIVALENT	1
GX CORPORATION SDN BHD
	SUBSTANTIALLY EQUIVALENT	14
HARTALEGA SDN BHD
	SUBSTANTIALLY EQUIVALENT	14
HIGH MOMENTUM SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
HL RUBBER INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	4
HONG XIN RUBBER PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HONGYE PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
INNOVATIVE GLOVES CO; LTD
	SUBSTANTIALLY EQUIVALENT	4
KIMBERLY-CLARK CORP.
	SUBSTANTIALLY EQUIVALENT	6
KOSSAN LATEX
	SUBSTANTIALLY EQUIVALENT	7
LAGLOVE (M) SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	9
LIWE TRADING
	SUBSTANTIALLY EQUIVALENT	2
MATANG MFG. SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	3
MAXXIM MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
MEDLINE
	SUBSTANTIALLY EQUIVALENT	6
MEDTEXX MANUFACTURING SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
MOLNLYCKE HEALTH CARE
	SUBSTANTIALLY EQUIVALENT	1
MULTISAFE SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
N.S. UNI-GLOVES SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	3
NITRITEX (M) SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
P.T. HEALTHCARE GLOVINDO
	SUBSTANTIALLY EQUIVALENT	2
PLATINUM GLOVE INDUSTRIES SDN.BHD.
	SUBSTANTIALLY EQUIVALENT	5
PT. MAHAKARYA INTI BUANA
	SUBSTANTIALLY EQUIVALENT	4
PT. MEDISAFE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	8
PURTECH CLEANROOM PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
QUALITY GALLANT SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
SGMP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
SHANGHAI CHINASTAR CORP.
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI MOTEX HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SHEN WEI (USA), INC.
	SUBSTANTIALLY EQUIVALENT	18
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIAM SEMPERMED CORP. LTD.
	SUBSTANTIALLY EQUIVALENT	16
SMART GLOVE CORP. SDN BHD
	SUBSTANTIALLY EQUIVALENT	16
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
	SUBSTANTIALLY EQUIVALENT	8
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TERANG NUSA SDN BHD
	SUBSTANTIALLY EQUIVALENT	3
TILLOTSON HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	4
ULTRAWIN SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
WEAR SAFE
	SUBSTANTIALLY EQUIVALENT	3
WRP ASIA PACIFIC
	SUBSTANTIALLY EQUIVALENT	9
YTY INDUSTRY
	SUBSTANTIALLY EQUIVALENT	7

Device Problems
No Known Device Problem	2
Reaction	1
Other (for use when an appropriate device code cannot be identified)	1
Unknown (for use when the device problem is not known)	1
Total Device Problems	5