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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
ALLMED MEDICAL (HUBEI) PROTECTIVE PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AMD MEDICOM INC.
  SUBSTANTIALLY EQUIVALENT 1
AZAC GROUP
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHONGQING LITAI FASHION GROUP LIMITED COMPANY
  SUBSTANTIALLY EQUIVALENT 1
COPIOUMED INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
CROWN NAME DISPOSABLE HYGIENE PRODUCTS FTY.LTD.
  SUBSTANTIALLY EQUIVALENT 1
FLOMAK TEKSTIL MAKINE MUH. MUM. TAAH. SAN. TIC. LTD. STI.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN NANHAI PLUS MEDICAL CO LTD
  SUBSTANTIALLY EQUIVALENT 1
GRI-ALLESET, INC
  SUBSTANTIALLY EQUIVALENT 1
HUBEI XINXIN NON-WOVEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUBEI XINXIN NON-WOVEN CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KENPAX INTERNATIONAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTECS (TAIWAN) CORP.
  SUBSTANTIALLY EQUIVALENT 1
NANNING TECBOD BIOLOGICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
PANEFFORT, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRIMED MEDICAL PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
STRING KING LACROSSE, LLC
  SUBSTANTIALLY EQUIVALENT 1
WILDCAT PPE, LLC
  SUBSTANTIALLY EQUIVALENT 1
WUHAN DYMEX HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN PROBTAIN MEDICAL TECHOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
YANBIAN PACIFIC TEXTILE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2019 1 1
2020 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 1 1
Defective Device 1 1
Insufficient Information 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Hypersensitivity/Allergic reaction 1 1
Itching Sensation 1 1
Rash 1 1
Urticaria 1 1

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