TPLC - Total Product Life Cycle

• Device: gown, surgical
• Product Code: FYA
• Regulation Number: 878.4040
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3A MEDICAL PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
3M COMPANY CORP
	SUBSTANTIALLY EQUIVALENT	1
A PLUS INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALLMED MEDICAL (HUBEI) PROTECTIVE PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
AMMEX-WEIDA (HUBEI) HEALTH AND SAFETY PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ANHUI MEDPUREST MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BAM CORP., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BARCO TEKSTIL SANAYI VE TICARET A.S.
	SUBSTANTIALLY EQUIVALENT	1
BAYTEKS TEKNIK TEKSTIL SAN. VE TIC. A.S.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH 200, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH 200, LLC
	SUBSTANTIALLY EQUIVALENT	4
CARDINAL HEALTH LLC
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU HOLYMED PRODUCTS CO LTD
	SUBSTANTIALLY EQUIVALENT	1
COBES INDUSTRIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY
	SUBSTANTIALLY EQUIVALENT	1
DUKAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ELEVATE TEXTILES
	SUBSTANTIALLY EQUIVALENT	1
EXACT MEDICAL MANUFACTURING, INC
	SUBSTANTIALLY EQUIVALENT	3
EXCELLENT MEDICAL TECHNOLOGY GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FELIKS PLASTIK LAMINASYON VE AMBALAJ MALZEMELERI
	SUBSTANTIALLY EQUIVALENT	1
FELIKS PLASTIK LAMINASYON VE AMBALAJ MALZEMELERI SANAYI
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN NANHAI PLUS MEDICAL CO LTD
	SUBSTANTIALLY EQUIVALENT	3
FOSHAN NANHAI PLUS MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
FUGOU COUNTY SHENXIANG MANUFACTURING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GMAX INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU FUZELONG HYGIENE MATERIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HALYARD HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU ATEK MEDICAL & TEXTILE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU JINCHENG MEDICAL SUPPLIER MANUFACTURE CO.
	SUBSTANTIALLY EQUIVALENT	1
HENAN ROBESTAIN MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HENAN YADU INDUSTRIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUBEI WANLI PROTECTIVE PRODUCTS CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
HUBEI WOOZON HEALTHCARE CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU MEDPLUS NON-WOVEN MANUFACTURER CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
KIMBERLY-CLARK CORP.
	SUBSTANTIALLY EQUIVALENT	3
KIMBERLY-CLARK CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LAC MAC, LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDCARE SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES LP
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	5
MEDLINE INDUSTRIES, LP.
	SUBSTANTIALLY EQUIVALENT	1
MICROTEK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
NANNING TECBOD BIOLOGICAL TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
O&M HALYARD, INC
	SUBSTANTIALLY EQUIVALENT	2
O&M HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
OMNIA SPA
	SUBSTANTIALLY EQUIVALENT	1
OPERATING ROOM INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
PROMEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SEJONG HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG KANGLI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SKLAR CORP.
	SUBSTANTIALLY EQUIVALENT	1
SKYPRO MEDICAL SUPPLIES COMPANY
	SUBSTANTIALLY EQUIVALENT	1
SRI SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
STRINGKING
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
SUZHOU JANEE MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
UNICOGLOBAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNIMAX MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WEIHAI DISHANG MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WINNER MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN DYMEX HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN ZONSEN MEDICAL PRODUCTS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
WUJIANG TUTAIKE TEXTILES & FINISHING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
XIAMEN PROBTAIN MEDICAL TECHOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XIANNING MARVELDAS PROTECTIVE ARTICLES CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO DINGCHENG NON-WOVEN PRODUCT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO RHYCOM NON-WOVEN PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO TOPMED NONWOVEN PROTECTIVE PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIANTAO ZHIBO NON-WOVEN PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,L
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER SURGICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2014	42	42
2015	59	59
2016	43	43
2017	66	66
2018	98	98
2019	38	49
2020	31	34
2021	15	15
2022	4	5
2023	13	17
2024	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Contamination with Chemical or Other Material	106	111
Material Split, Cut or Torn	58	70
Material Integrity Problem	56	56
Torn Material	54	54
Material Separation	26	26
Fluid/Blood Leak	13	13
Delivered as Unsterile Product	13	15
Hole In Material	12	12
Material Puncture/Hole	10	10
Device Contamination with Body Fluid	9	9
No Apparent Adverse Event	9	9
Protective Measures Problem	9	9
Adverse Event Without Identified Device or Use Problem	7	7
Material Fragmentation	7	7
Contamination	7	7
Appropriate Term/Code Not Available	6	6
Insufficient Information	5	5
Device Operates Differently Than Expected	5	5
Patient-Device Incompatibility	5	5
Material Frayed	5	5
Improper or Incorrect Procedure or Method	5	5
Use of Device Problem	4	4
Break	4	4
Therapeutic or Diagnostic Output Failure	4	4
Defective Device	3	3
Contamination /Decontamination Problem	3	3
Delamination	3	3
Packaging Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Product Quality Problem	3	3
Device Emits Odor	2	2
Detachment Of Device Component	2	2
Component Falling	2	2
Leak/Splash	2	2
Shipping Damage or Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Smoking	2	2
Microbial Contamination of Device	2	2
Tear, Rip or Hole in Device Packaging	2	2
Device Packaging Compromised	2	2
Compatibility Problem	2	2
Device Contamination With Biological Material	2	2
Device Misassembled During Manufacturing /Shipping	1	1
Detachment of Device or Device Component	1	1
Contamination of Device Ingredient or Reagent	1	1
Chemical Spillage	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Distortion	1	1
Cut In Material	1	1
Failure to Align	1	1
Expiration Date Error	1	1
Strikethrough	1	1
Component Missing	1	1
Residue After Decontamination	1	1
Defective Component	1	1
Device Reprocessing Problem	1	1
Crack	1	1
Device Expiration Issue	1	1
Overheating of Device	1	1
Failure to Power Up	1	1
Image Display Error/Artifact	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	131	138
No Consequences Or Impact To Patient	113	118
No Patient Involvement	89	93
No Clinical Signs, Symptoms or Conditions	21	28
Exposure to Body Fluids	16	16
No Information	12	12
Rash	11	11
Insufficient Information	8	8
Missing Value Reason	4	4
Local Reaction	4	4
Hypersensitivity/Allergic reaction	4	4
Skin Irritation	3	3
Foreign Body In Patient	3	3
Itching Sensation	2	2
Chemical Exposure	2	2
Urticaria	2	2
Reaction	2	2
Swelling	2	2
No Code Available	2	2
Not Applicable	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Visual Impairment	1	1
Skin Discoloration	1	1
Irritation	1	1
Erythema	1	1
Hair Loss	1	1
Caustic/Chemical Burns	1	1
Patient Problem/Medical Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	American Contract Systems, Inc.	II	Feb-27-2019
2	Cardinal Health	II	Dec-10-2021
3	Cardinal Health	II	Jan-24-2020
4	Customed, Inc	II	Apr-14-2016
5	Customed, Inc	II	Sep-03-2015
6	Customed, Inc	I	Dec-16-2014
7	EXP Pharmaceutical Services Corp	II	Jul-24-2015
8	Kimberly-Clark Corporation	II	Nov-07-2012
9	Kimberly-Clark Corporation	II	Jul-16-2012
10	Kimberly-Clark Corporation	II	Jan-18-2011
11	MEDLINE INDUSTRIES, LP - Northfield	II	Jan-11-2024
12	Master & Frank (Pinghu) Co., Ltd.	II	Aug-28-2017
13	Microtek Medical Inc	II	Mar-27-2015
14	Owens & Minor Distribution, Inc.	II	Dec-06-2022
15	Stryker Instruments Div. of Stryker Corporation	II	Apr-24-2018
16	Stryker Instruments Div. of Stryker Corporation	III	Feb-10-2015
17	Stryker Instruments Div. of Stryker Corporation	II	Jun-06-2013
18	Stryker Instruments Div. of Stryker Corporation	II	Jun-14-2012
19	THREAD COUNSEL INC DBA LAWS OF MOTION	II	Oct-26-2020
20	Texas Medical Technology Inc.	II	Nov-16-2022