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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
BARCO TEKSTIL SANAYI VE TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
BAYTEKS TEKNIK TEKSTIL SAN. VE TIC. A.S.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING BIOSIS HEALING BIOLOG ICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH200, LLC
  SUBSTANTIALLY EQUIVALENT 1
COPIOUMED INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DAE MYUNG CHEMICAL CO., LTD. (VIETNAM)
  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 4
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, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 3
NANNING TECBOD BIOLOGICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
O&M HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEJONG HEALTHCARE 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
THI TOTAL HEALTHCARE INNOVATION GMBH
  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
YADU MEDICAL (HENAN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 15 15
2022 4 5
2023 12 16
2024 27 36
2025 14 18
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 9 9
Material Integrity Problem 7 7
Device Contamination with Chemical or Other Material 7 12
Device Contaminated During Manufacture or Shipping 5 14
Contamination 5 5
Delivered as Unsterile Product 5 9
Accessory Incompatible 3 3
Material Puncture/Hole 3 3
Product Quality Problem 3 3
Component Incompatible 3 3
Break 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Fragmentation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Frayed 1 1
Compatibility Problem 1 1
Material Split, Cut or Torn 1 1
Mechanical Problem 1 1
Crack 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Microbial Contamination of Device 1 1
Unraveled Material 1 1
Use of Device Problem 1 1
Component Missing 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Improper or Incorrect Procedure or Method 1 1
Fluid/Blood Leak 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 36 54
Insufficient Information 8 8
Local Reaction 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Rash 5 5
Exposure to Body Fluids 4 4
Post Operative Wound Infection 4 4
Foreign Body In Patient 3 3
Skin Burning Sensation 1 1
Swelling/ Edema 1 1
Chemical Exposure 1 1
Hypersensitivity/Allergic reaction 1 1
Itching Sensation 1 1
Anaphylactoid 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Dec-10-2021
2 Cardinal Health 200, LLC II Dec-11-2025
3 MEDLINE INDUSTRIES, LP - Northfield II Jan-11-2024
4 Medline Industries, LP II Feb-17-2026
5 Owens & Minor Distribution, Inc. II Dec-06-2022
6 Texas Medical Technology Inc. II Nov-16-2022
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