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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gown, surgical
Product CodeFYA
Regulation Number 878.4040
Device Class 2


Premarket Reviews
ManufacturerDecision
3A MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ALLMED MEDICAL (HUBEI) PROTECTIVE 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
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, LLC
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH LLC
  SUBSTANTIALLY EQUIVALENT 1
DUKAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ELEVATE TEXTILES
  SUBSTANTIALLY EQUIVALENT 1
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 1
FUGOU COUNTY SHENXIANG MANUFACTURING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GMAX INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU FUZELONG HYGIENE MATERIAL CO., LTD
  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
JIANGSU MEDPLUS NON-WOVEN MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES LP
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDLINE INDUSTRIES, LP.
  SUBSTANTIALLY EQUIVALENT 1
O&M HALYARD, INC
  SUBSTANTIALLY EQUIVALENT 2
O&M HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPERATING ROOM INNOVATIONS, INC.
  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
STRINGKING
  SUBSTANTIALLY EQUIVALENT 1
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
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
XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 98 98
2019 38 49
2020 31 34
2021 15 15
2022 4 5
2023 2 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 58 70
Torn Material 37 37
Material Separation 21 21
Material Integrity Problem 21 21
Device Contamination with Chemical or Other Material 14 17
Fluid/Blood Leak 11 11
Material Puncture/Hole 10 10
Delivered as Unsterile Product 9 11
No Apparent Adverse Event 8 8
Adverse Event Without Identified Device or Use Problem 5 5
Material Frayed 4 4
Therapeutic or Diagnostic Output Failure 4 4
Use of Device Problem 4 4
Contamination 4 4
Improper or Incorrect Procedure or Method 3 3
Device Contamination with Body Fluid 3 3
Delamination 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Break 2 2
Defective Device 2 2
Leak/Splash 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Emits Odor 2 2
Smoking 2 2
Contamination /Decontamination Problem 2 2
Product Quality Problem 2 2
Patient-Device Incompatibility 1 1
Appropriate Term/Code Not Available 1 1
Shipping Damage or Problem 1 1
Device Packaging Compromised 1 1
Protective Measures Problem 1 1
Material Fragmentation 1 1
Hole In Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Detachment of Device or Device Component 1 1
Packaging Problem 1 1
Crack 1 1
Overheating of Device 1 1
Microbial Contamination of Device 1 1
Failure to Align 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 56 61
No Known Impact Or Consequence To Patient 53 60
No Patient Involvement 39 43
No Clinical Signs, Symptoms or Conditions 16 21
Exposure to Body Fluids 9 9
Insufficient Information 8 8
No Information 6 6
Missing Value Reason 4 4
Rash 2 2
Skin Irritation 1 1
Erythema 1 1
Patient Problem/Medical Problem 1 1
Hypersensitivity/Allergic reaction 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hair Loss 1 1
Urticaria 1 1
Chemical Exposure 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 Owens & Minor Distribution, Inc. II Dec-06-2022
5 Stryker Instruments Div. of Stryker Corporation II Apr-24-2018
6 THREAD COUNSEL INC DBA LAWS OF MOTION II Oct-26-2020
7 Texas Medical Technology Inc. II Nov-16-2022
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