FDA.reportPublic FDA data

Isolation Gown High Risk With Tape

Primary DI
04710415363480
Brand
Isolation Gown High Risk With Tape
Company
MEDTECS (TAIWAN) CORP.
Model
IL-4036YKTP
Published
2023-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
94710415369010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

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

Regulatory Flags#

DUNS number
658023890
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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
00850047202291NITRILE EXAM GLOVES-Black-200pcs-XSBlack-200pcs-XS2023-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813360021475ProtexerICP MEDICAL, LLCFYC2025-08-15
10813360021472ProtexerICP MEDICAL, LLCFYC2025-08-15
00813360021468ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162000030ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162290004ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162390506ProtexerICP MEDICAL, LLCFYC2025-08-08
10813360021465ProtexerICP MEDICAL, LLCFYC2025-08-08
00813360021772ProtexerICP MEDICAL, LLCFYC2025-08-08
00842942015175PRIMEDpriMED Medical Products IncFYC2025-07-21
00842942015304PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015172PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015301PRIMEDpriMED Medical Products IncFYC2025-07-21
04719882251399CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251412CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251436CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251450CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251559CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251573CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251597CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251610CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251719CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251733CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251757CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251771CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251396CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251419CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251433CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251457CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251556CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251570CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16