FDA.reportPublic FDA data

Gredale USA-Made AAMI Level 3 Surgical Gown (X-Large)

Primary DI
20860008925750
Brand
Gredale USA-Made AAMI Level 3 Surgical Gown (X-Large)
Company
Gredale LLC
Model
GRE3000-XL
Device description
Gredale USA-Made AAMI Level 3 Surgical Gown (X-Large)
Published
2022-08-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYAGown, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860008925750PackageGS110In Commercial Distribution
10860008925753PrimaryGS10
00860008925749Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086000892575020860008925750
1086000892575310860008925753
00860008925749008600089257498600089257490860008925749

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

Contacts#

Phone, Email table
PhoneEmail
(323) 210-3951shop@gredale.com

Regulatory Flags#

DUNS number
079303209
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860008925722Gredale USA-Made AAMI Level 1 Isolation Gown (Large)GRE1000-L2022-08-23
10860008925739Gredale USA-Made AAMI Level 1 Isolation Gown (X-Large)GRE1000-XL2022-08-23
10860008925746Gredale USA-Made AAMI Level 3 Surgical Gown (Large)GRE3000-L2022-08-23
10860008925753Gredale USA-Made AAMI Level 3 Surgical Gown (X-Large)GRE3000-XL2022-08-23
20860008925729Gredale USA-Made AAMI Level 1 Isolation Gown (Large)GRE1000-L2022-08-23
20860008925736Gredale USA-Made AAMI Level 1 Isolation Gown (X-Large)GRE1000-XL2022-08-23
20860008925743Gredale USA-Made AAMI Level 3 Surgical Gown (Large)GRE3000-L2022-08-23
10860008925708Gredale USA-Made AAMI Level 2 Isolation Gown (Large)GRE2000-L2022-07-12
10860008925715Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large)GRE2000-XL2022-07-12
20860008925705Gredale USA-Made AAMI Level 2 Isolation Gown (Large)GRE2000-L2022-07-12
20860008925712Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large)GRE2000-XL2022-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918123325AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-06-04
08809518442430SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442447SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
20888277720050MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-11
20888277419879MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277419886MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277660905MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674704MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674711MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674728MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674735MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
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