FDA.reportPublic FDA data

3A MEDICAL

Primary DI
00850029191117
Brand
3A MEDICAL
Company
3A Medical Products Co.,Ltd
Model
S3002
Device description
Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407
Published
2021-03-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
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
00850029191117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850029191117008500291911178500291911170850029191117

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00avoid contact with an open flame or high intensity heat source

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
705-232-1615service@hilo8a.com

Regulatory Flags#

DUNS number
544515279
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008500291910013A MEDICALS30012021-03-09
008500291910253A MedicalS30032021-03-03
008500291910323A MedicalS30042021-03-03
008500291910493A MedicalS30052021-03-03
008500291912093A MEDICAL210012021-03-18
008500291912163A MEDICAL3AJS00012021-03-18
008500291912233A MEDICAL310012021-03-18
008500291912303A MEDICAL210012021-03-18
008500291910633A MEDICALS40022021-03-10
008500291910703A MEDICALS40032021-03-10
008500291910873A MEDICALS40042021-03-10
008500291910943A MEDICALS40052021-03-10
008500291911003A MEDICALS30012021-03-10
008500291911553A MEDICALS40012021-03-10
008500291911623A MEDICALS40022021-03-10
008500291911793A MEDICALS40032021-03-10
008500291911863A MEDICALS40042021-03-10
008500291911933A MEDICALS40052021-03-10
008500291910183A MEDICALS30022021-03-09
008500291910563A MEDICALS40012021-03-09

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
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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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