TPLC - Total Product Life Cycle

• Device: vinyl patient examination glove
• Definition: A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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: LYZ
• Regulation Number: 880.6250
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
ANHUI BYTECH MEDICAL SUPPLIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ANHUI INTCO MEDICAL PRODUCTS CO. LTD
	SUBSTANTIALLY EQUIVALENT	2
ANHUI POWERGUARD TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
BEST CARE TRADING CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BETTER HEALTH MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BYTECH(DONGTAI) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHIFENG HUAWEI MEDICAL SCIENCE&TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
DEZHOU HENGCHANG MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DEZHOU HENGCHANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
EVER GLOBAL (VIETNAM) ENTERPRISE CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
GRAND WORK PLASTIC PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG KINGFA SCI.& TECH.CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI ASTRO MEDICAL SUPPLY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNER MONGOLIA CUREGUARD MEDICAL MATERIALS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CUREGUARD GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU DIHONG INDUSTRY AND TRADE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HUAYUAN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI HANDSPRO PRODUCTS SOLUTIONS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI JAYSUN MEDCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI SHENGDA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LIAO NING SHANGWEI MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LIUPING TRADING CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUTAI MEDICAL TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
SHANDONG HONGXIN CHEMICALS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG JIESHI MEDICAL PRODUCTS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG LANGTAI INTERNATIONAL TRADE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG SHENGSHIXINCHENG MEDICAL SCIENCE & TECHNOLOGY CO.,
	SUBSTANTIALLY EQUIVALENT	2
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI SHENGDA MEDICAL APPLICATIONS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHEN WEI USA INC.
	SUBSTANTIALLY EQUIVALENT	1
SHIJIAZHUANG HONGJUN PLASTIC MANUFACTURE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAIAN HENGCHANG MEDICAL TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
TANGSHAN HONGYUN HEALTHCARE PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TANGSHAN HONGYUN HEALTHCARE PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TOP GLOVE VIETNAM COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
XINYING TRADING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YUNNAN HUAZHIYUAN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	3	3
2020	1	1
2021	4	4
2022	1	1
2023	1	1
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Puncture/Hole	2	2
Patient-Device Incompatibility	2	2
Material Split, Cut or Torn	2	2
Contamination /Decontamination Problem	1	1
Insufficient Information	1	1
Patient Device Interaction Problem	1	1
Material Separation	1	1
Device Contamination with Body Fluid	1	1
Defective Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Chemical Exposure	2	2
Insufficient Information	2	2
No Clinical Signs, Symptoms or Conditions	1	1
No Patient Involvement	1	1
No Known Impact Or Consequence To Patient	1	1
Skin Inflammation/ Irritation	1	1
Exposure to Body Fluids	1	1
Death	1	1
Hypersensitivity/Allergic reaction	1	1
Anaphylactoid	1	1