FDA.reportPublic FDA data

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown

Primary DI
94710415369010
Brand
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown
Company
MEDTECS (TAIWAN) CORP.
Model
IL-4036YKTP-L4
Published
2023-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FYCGown, Isolation, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYCGown, Isolation, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04710415363480PrimaryGS10
04710415369017PrimaryGS10
94710415369010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710415363480047104153634804710415363480
04710415369017047104153690174710415369017
9471041536901094710415369010

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658023890
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850047202161NITRILE EXAM GLOVES-Blue-200pcs-LBlue-200pcs-L2023-06-17
00850047202178NITRILE EXAM GLOVES-Blue-200pcs-MBlue-200pcs-M2023-06-17
00850047202185NITRILE EXAM GLOVES-Blue-200pcs-SBlue-200pcs-S2023-06-17
00850047202192NITRILE EXAM GLOVES-Blue-200pcs-XSBlue-200pcs-XS2023-06-17
00850047202208NITRILE EXAM GLOVES-Cool Blue-200pcs-XLCool Blue-200pcs-XL2023-06-17
00850047202215NITRILE EXAM GLOVES-Cool Blue-200pcs-LCool Blue-200pcs-L2023-06-17
00850047202239NITRILE EXAM GLOVES-Cool Blue-200pcs-SCool Blue-200pcs-S2023-06-17
00850047202277NITRILE EXAM GLOVES-Black-200pcs-MBlack-200pcs-M2023-06-17
00850047202284NITRILE EXAM GLOVES-Black-200pcs-SBlack-200pcs-S2023-06-17
00850047202154NITRILE EXAM GLOVES-Blue-200pcs-XLBlue-200pcs-XL2023-06-17
04710415363480Isolation Gown High Risk With TapeIL-4036YKTP2023-12-18
00850047202505NITRILE EXAM GLOVES-Black-100pcs-XLBlack-100pcs-XL2023-11-08
00850047202512NITRILE EXAM GLOVES-Black-100pcs-LBlack-100pcs-L2023-11-08
00850047202529NITRILE EXAM GLOVES-Black-100pcs-MBlack-100pcs-M2023-11-08
00850047202536NITRILE EXAM GLOVES-Black-100pcs-SBlack-100pcs-S2023-11-08
00850047202543NITRILE EXAM GLOVES-Black-100pcs-XSBlack-100pcs-XS2023-11-08
00850047202222NITRILE EXAM GLOVES-Cool Blue-200pcs-MCool Blue-200pcs-M2023-06-17
00850047202246NITRILE EXAM GLOVES-Cool Blue-200pcs-XSCool Blue-200pcs-XS2023-06-17
00850047202253NITRILE EXAM GLOVES-Black-200pcs-XLBlack-200pcs-XL2023-06-17
00850047202260NITRILE EXAM GLOVES-Black-200pcs-LBlack-200pcs-L2023-06-17

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Primary DI, Brand, Company table
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00688162290004ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162390506ProtexerICP MEDICAL, LLCFYC2025-08-08
10813360021465ProtexerICP MEDICAL, LLCFYC2025-08-08
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