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	20	20
Material Split, Cut or Torn	19	19
Material Separation	14	14
Material Fragmentation	10	10
Break	8	8
Material Integrity Problem	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Product Quality Problem	7	7
Patient Device Interaction Problem	5	5
Inadequacy of Device Shape and/or Size	4	4
Structural Problem	4	4
Defective Device	3	3
Contamination	3	3
Material Discolored	2	3
Delivered as Unsterile Product	2	3
Tear, Rip or Hole in Device Packaging	2	2
Insufficient Information	2	2
Device Contamination with Chemical or Other Material	2	2
Human-Device Interface Problem	2	2
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Packaging Problem	1	1
No Apparent Adverse Event	1	1
Material Twisted/Bent	1	1
Device Emits Odor	1	2
Flaked	1	1
Patient-Device Incompatibility	1	1
Contamination /Decontamination Problem	1	2
Problem with Sterilization	1	2
Use of Device Problem	1	1
Material Perforation	1	1
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	68	68
Foreign Body In Patient	19	19
Insufficient Information	15	15
Hypersensitivity/Allergic reaction	6	6
Itching Sensation	3	3
Rash	3	3
Swelling/ Edema	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Skin Inflammation/ Irritation	2	2
Erythema	2	2
Unspecified Infection	1	2
Toxic Anterior Segment Syndrome (TASS)	1	1
Post Operative Wound Infection	1	1
Burning Sensation	1	1
Exposure to Body Fluids	1	1
Anaphylactic Shock	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
4	Medline Industries, LP	I	Apr-07-2026