FDA.reportPublic FDA data

Copioumed

Primary DI
04719882251887
Brand
Copioumed
Company
COPIOUMED INTERNATIONAL INC.
Model
SGS3B101-1
Device description
Copioumed AAMI 3 Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect both surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate materials. The gown is single-use, disposable, and provided sterile, and is classified as AAMI Level 3.
Published
2026-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
14719882251884PackageGS130In Commercial Distribution
04719882251887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988225188414719882251884
04719882251887047198822518874719882251887

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment intended to be worn by healthcare staff 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.

Contacts#

Phone, Email table
PhoneEmail
+886227721815info@gcv.com.tw

Regulatory Flags#

DUNS number
658318113
Device count
1
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719882251399CopioumedCTN3B101-12025-07-16
04719882251412CopioumedCTN3B102-12025-07-16
04719882251436CopioumedCTN3B103-12025-07-16
04719882251450CopioumedCTN3B104-12025-07-16
04719882251559CopioumedCTN3B201-12025-07-16
04719882251573CopioumedCTN3B202-12025-07-16
04719882251597CopioumedCTN3B203-12025-07-16
04719882251610CopioumedCTN3B204-12025-07-16
04719882251719CopioumedCTN3B301-12025-07-16
04719882251733CopioumedCTN3B302-12025-07-16
04719882251757CopioumedCTN3B303-12025-07-16
04719882251771CopioumedCTN3B304-12025-07-16
14719882251396CopioumedCTN3B101-12025-07-16
14719882251419CopioumedCTN3B102-12025-07-16
14719882251433CopioumedCTN3B103-12025-07-16
14719882251457CopioumedCTN3B104-12025-07-16
14719882251556CopioumedCTN3B201-12025-07-16
14719882251570CopioumedCTN3B202-12025-07-16
14719882251594CopioumedCTN3B203-12025-07-16
14719882251617CopioumedCTN3B204-12025-07-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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