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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gown, surgical
Regulation Description Surgical apparel.
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
GEORGE COUREY 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
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 2
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP.
  SUBSTANTIALLY EQUIVALENT 1
NANNING TECBOD BIOLOGICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
O&M HALYARD, INC
  SUBSTANTIALLY EQUIVALENT 2
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
STANDARD TEXTILE CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
STRINGKING
  SUBSTANTIALLY EQUIVALENT 1
STRYKER INSTRUMENTS
  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 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

MDR Year MDR Reports MDR Events
2020 31 34
2021 15 15
2022 4 5
2023 13 17
2024 27 36
2025 6 10

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 10 13
Material Puncture/Hole 8 8
Material Integrity Problem 8 8
Device Contamination with Chemical or Other Material 7 12
Delivered as Unsterile Product 6 10
Contamination 5 5
Therapeutic or Diagnostic Output Failure 4 4
Appropriate Term/Code Not Available 4 4
Device Contaminated During Manufacture or Shipping 3 12
Accessory Incompatible 3 3
Use of Device Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Product Quality Problem 3 3
No Apparent Adverse Event 3 3
Component Incompatible 3 3
Material Frayed 2 2
Compatibility Problem 2 2
Break 2 2
Patient-Device Incompatibility 2 2
Defective Device 2 2
Improper or Incorrect Procedure or Method 2 2
Leak/Splash 1 1
Crack 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Microbial Contamination of Device 1 1
Contamination /Decontamination Problem 1 1
Material Fragmentation 1 1
Shipping Damage or Problem 1 1
Unraveled Material 1 1
Failure to Align 1 1
Packaging Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Detachment of Device or Device Component 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 36 56
No Known Impact Or Consequence To Patient 16 16
Local Reaction 8 8
Insufficient Information 8 8
Exposure to Body Fluids 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Consequences Or Impact To Patient 5 6
Rash 4 4
Missing Value Reason 4 4
Foreign Body In Patient 3 3
No Patient Involvement 2 3
Urticaria 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Irritation 1 1
Anaphylactoid 1 1
Chemical Exposure 1 1
Erythema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Dec-10-2021
2 Cardinal Health II Jan-24-2020
3 MEDLINE INDUSTRIES, LP - Northfield II Jan-11-2024
4 Owens & Minor Distribution, Inc. II Dec-06-2022
5 THREAD COUNSEL INC DBA LAWS OF MOTION II Oct-26-2020
6 Texas Medical Technology Inc. II Nov-16-2022
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