TPLC - Total Product Life Cycle

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Device	medical glove, specialty
Definition	A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.
Product Code	LZC
Regulation Number	880.6250
Device Class	1

Premarket Reviews
Manufacturer	Decision
0 & M HALYARD, INC
	SUBSTANTIALLY EQUIVALENT	1
ANHUI XINYISHENG MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ASPEN GLOVE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
BETTER CARE PLASTIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CENTRAL MEDICARE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU UNIVERSAL MEDICAL EQUIPMENT CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
ENCOMPASS INDUSTRIES SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
EVER GLOBAL (VIETNAM) ENTERPRISE CORP
	SUBSTANTIALLY EQUIVALENT	1
GMP MEDICARE SDN BHD (F25)
	SUBSTANTIALLY EQUIVALENT	1
HAINAN ASTHER MEDICAL EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HL RUBBER INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU NANFANG MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN.BHD.
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE INDUSTIRES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NIUJIAN TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
O & M HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
SHOWA BEST GLOVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
YTY INDUSTRY (MANJUNG) SDN BHD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Split, Cut or Torn	5	5
Patient-Device Incompatibility	3	3
Contamination of Device Ingredient or Reagent	2	2
Material Rupture	1	1
Component Incompatible	1	1
Break	1	1
Physical Resistance/Sticking	1	1
Contamination /Decontamination Problem	1	1
Material Discolored	1	1
Degraded	1	1
Device Contaminated During Manufacture or Shipping	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	6	6
No Clinical Signs, Symptoms or Conditions	4	4
Swelling/ Edema	2	2
Sore Throat	2	2
Insufficient Information	2	2
Inflammation	1	1
Superficial (First Degree) Burn	1	1
Local Reaction	1	1
Skin Irritation	1	1
Skin Inflammation/ Irritation	1	1
No Code Available	1	1