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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 200, LLC
  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
HINDERNIS DE MEXICO, S.A.P.I. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
HUBEI WANLI PROTECTIVE PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUBEI WOOZON HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUBEI XINXIN NON-WOVEN 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
NEW YORK EMBROIDERY STUDIO (NYES)
  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 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
Appropriate Term/Code Not Available 10 10
Material Integrity Problem 7 7
Contamination 7 7
Device Contamination with Chemical or Other Material 7 12
Device Contaminated During Manufacture or Shipping 5 14
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
Material Frayed 1 1
Compatibility Problem 1 1
Material Split, Cut or Torn 1 1
Mechanical Problem 1 1
Off-Label Use 1 1
Physical Resistance/Sticking 1 1
Crack 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 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 37 55
Hypersensitivity/Allergic reaction 12 12
Insufficient Information 11 11
Local Reaction 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Post Operative Wound Infection 5 5
Rash 5 5
Exposure to Body Fluids 4 4
Foreign Body In Patient 3 3
Itching Sensation 1 1
Anaphylactoid 1 1
Chemical Exposure 1 1
Post Traumatic Wound Infection 1 1
Swelling/ Edema 1 1
Skin Burning Sensation 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 May-07-2026
5 Medline Industries, LP II Mar-12-2026
6 Medline Industries, LP II Feb-17-2026
7 Owens & Minor Distribution, Inc. II Dec-06-2022
8 Texas Medical Technology Inc. II Nov-16-2022
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