TPLC - Total Product Life Cycle

show TPLC since

Device	medical glove, specialty
Regulation Description	Non-powdered patient examination glove.
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
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
CARDINALHEALTH
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU UNIVERSAL MEDICAL EQUIPMENT CO., LTD.
	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
LINGSHI HONGRUIDA HEALTH PROTECTION TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NIUJIAN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Component Incompatible	8	8
Material Split, Cut or Torn	6	6
Device Damaged Prior to Receipt by User	6	6
Defective Device	1	1
Non Reproducible Results	1	1
Appropriate Device Problem Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	26	26
Local Reaction	5	5
Insufficient Information	3	3
Sore Throat	2	2
Swelling/ Edema	2	2
Contact Dermatitis	2	2
Anaphylactoid / Anaphylaxis	1	1
Inflammation	1	1
Superficial (First Degree) Burn	1	1