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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
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
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 3
CARDINAL HEALTH LLC
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY
  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
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
HUBEI WOOZON HEALTHCARE 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
MEDCARE SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES LP
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDLINE INDUSTRIES, LP.
  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
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
SKYPRO MEDICAL SUPPLIES COMPANY
  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
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
ZIMMER SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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
Material Split, Cut or Torn 25 37
Material Puncture/Hole 10 10
Device Contamination with Chemical or Other Material 8 13
Material Integrity Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
No Apparent Adverse Event 5 5
Contamination 5 5
Delivered as Unsterile Product 5 7
Use of Device Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Appropriate Term/Code Not Available 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Material Frayed 3 3
Leak/Splash 2 2
Microbial Contamination of Device 2 2
Device Contamination with Body Fluid 2 2
Product Quality Problem 2 2
Break 2 2
Compatibility Problem 2 2
Defective Device 2 2
Patient-Device Incompatibility 2 2
Contamination /Decontamination Problem 2 2
Detachment of Device or Device Component 1 1
Device Contaminated During Manufacture or Shipping 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Smoking 1 1
Failure to Align 1 1
Overheating of Device 1 1
Crack 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 35 42
No Clinical Signs, Symptoms or Conditions 21 28
No Consequences Or Impact To Patient 13 18
Insufficient Information 8 8
No Patient Involvement 7 11
Exposure to Body Fluids 7 7
Rash 6 6
Local Reaction 4 4
No Information 4 4
Missing Value Reason 4 4
Foreign Body In Patient 2 2
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Skin Irritation 1 1
Urticaria 1 1
Chemical Exposure 1 1
Erythema 1 1
Hair Loss 1 1
Hypersensitivity/Allergic reaction 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 MEDLINE INDUSTRIES, LP - Northfield II Jan-11-2024
5 Owens & Minor Distribution, Inc. II Dec-06-2022
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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