FDA.reportPublic FDA data

NON-SURGICAL ISOLATION GOWN

Primary DI
06950471300106
Brand
NON-SURGICAL ISOLATION GOWN
Company
Hangzhou A-Tek Medical & Textiles Co., Ltd.
Model
28027
Device description
NON-SURGICAL ISOLATION GOWN, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY INFECTIOUS MATERIAL
Published
2023-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
06950471300106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950471300106069504713001066950471300106

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
547874292
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06950471300137DISPOSABLE HOT OR COLD PACK COVER280302023-07-21
06950471300144VACUUM COLLECTION BOTTLE280312023-07-21
06950471300151GAS COLLECTING VESSEL280322023-07-21
06950471300038DISPOSABLE BEDDING PRODUCTS280202023-07-18
06950471300045EXAMINATION GOWN280212023-07-18
06950471300052SURGICAL CAP280222023-07-18
06950471300069SURGICAL APPAREL ACCESSORY280232023-07-18
06950471300076OPERATING-ROOM SHOE COVER280242023-07-18
06950471300083SURGICAL GOWN280252023-07-18
06950471300113TABLE TRAY FOR OPERATING ROOM280282023-07-18
06950471300120CONDUCTIVE SHOE AND SHOE COVER280292023-07-18
06950471320067RESUABLE INCONTINENCE UNDERPAD280192023-07-18

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Primary DI, Brand, Company table
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