FDA.reportPublic FDA data

Disposable Isolation Gown

Primary DI
08936064200020
Brand
Disposable Isolation Gown
Company
TNG INVESTMENT AND TRADING JOINT STOCK COMPANY
Model
Y0146
Device description
Non-woven fabricGown with elastic band inside cuff, non-zipper, back tie,disposable
Published
2020-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08936064200020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08936064200020089360642000208936064200020

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
555325484
Device count
1
Premarket exempt
true
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
08936064200006Disposable Full BodysuitY02422020-08-13
08936064200013Disposable Isolation GownY01402020-08-13
08936064200037Disposable Full Bodysuit & AccessoriesY03662020-08-13
08936064200150DISPOSABLE MEDICAL MASKY03842020-08-13
08936064200167Disposable Boot CoverMDC-PS132020-08-13
08936064200174Disposable Medical CapMDCPH012020-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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