TPLC - Total Product Life Cycle

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Device	surgeon's gloves
Regulation Description	Non-powdered surgeon's glove.
Definition	A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Product Code	KGO
Regulation Number	878.4460
Device Class	1

Premarket Reviews
Manufacturer	Decision
AMAZING RUBBER PRODUCTS PVT, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ANSELL HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
ANSELL HEALTHCARE PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	2
ASPEN GLOVE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH200, LLC
	SUBSTANTIALLY EQUIVALENT	1
CAREPLUS (M) SDN BHD
	SUBSTANTIALLY EQUIVALENT	4
ECO MEDI GLOVE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
EMERSON & CO. SRL
	SUBSTANTIALLY EQUIVALENT	1
FITONE LATEX PRODUCTS CO., LTD. GUANGDONG
	SUBSTANTIALLY EQUIVALENT	1
GRAND WORK PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUILIN HBM HEALTH PROTECTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	2
GX CORPORATION SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
HARPS EUROPE MANUFACTURING GMBH
	SUBSTANTIALLY EQUIVALENT	1
HARTALEGA NGC SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
INEO TECH SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI KEMEI MEDICAL APPARATUS & INSTRUMENTS GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MRK HEALTHCARE PVT, LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEW ERA MEDICARE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
PENTAVEST HOLDINGS SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
PUYANG LINSHI MEDICAL SUPPLIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SENTIENX SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU COLOUR-WAY NEW MATERIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
THE EGYPTIAN COMPANY FOR MEDICAL & ELECTRONIC INDUSTRIES
	SUBSTANTIALLY EQUIVALENT	1
WRP ASIA PACIFIC SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Puncture/Hole	13	13
Material Split, Cut or Torn	10	10
Material Fragmentation	10	10
Material Separation	9	9
Material Integrity Problem	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Product Quality Problem	7	7
Break	6	6
Structural Problem	4	4
Inadequacy of Device Shape and/or Size	4	4
Contamination	3	3
Patient Device Interaction Problem	3	3
Insufficient Information	2	2
Material Discolored	2	3
Delivered as Unsterile Product	2	3
Human-Device Interface Problem	2	2
Device Contaminated During Manufacture or Shipping	1	1
Patient-Device Incompatibility	1	1
Defective Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Contamination /Decontamination Problem	1	2
Use of Device Problem	1	1
Component Missing	1	1
Material Twisted/Bent	1	1
Problem with Sterilization	1	2
Material Perforation	1	1
Device Emits Odor	1	2
Tear, Rip or Hole in Device Packaging	1	1
Device Contamination with Chemical or Other Material	1	1
Flaked	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	44	44
Foreign Body In Patient	19	19
Insufficient Information	13	13
Hypersensitivity/Allergic reaction	6	6
Rash	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Erythema	2	2
Unspecified Infection	1	2
Toxic Anterior Segment Syndrome (TASS)	1	1
Itching Sensation	1	1
Post Operative Wound Infection	1	1
Burning Sensation	1	1
Exposure to Body Fluids	1	1
Anaphylactic Shock	1	1
Swelling/ Edema	1	1
Caustic/Chemical Burns	1	1
Bacterial Infection	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ansell Healthcare Products LLC	II	Oct-11-2023
2	Ansell Healthcare Products LLC	II	Mar-30-2022
3	Cardinal Health 200, LLC	II	Apr-09-2022