FDA.reportPublic FDA data

GLOBAL HEALTHCARE

Primary DI
00872237009145
Brand
GLOBAL HEALTHCARE
Company
GHC HEALTHCARE, INC.
Model
07-21XXL
Device description
XXL Sterile Surgical Gown Level 3
Published
2020-08-04
Public version status
Update
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
FYAGown, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40872237009181PackageGS126In Commercial Distribution
00872237009145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4087223700918140872237009181
00872237009145008722370091458722370091450872237009145

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.

Regulatory Flags#

DUNS number
884718776
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00872237001804GLOBAL HEALTHCARE60-T022023-03-16
40872237001802GLOBAL HEALTHCARE60-T022023-03-16
00872237008568GLOBAL HEALTHCARE60-TN14012017-02-10
00872237001088GLOBAL HEALTHCARE63-45302017-02-10
00872237001095GLOBAL HEALTHCARE63-45312017-02-10
00872237001101GLOBAL HEALTHCARE63-45322017-02-10
00872237004256GLOBAL HEALTHCAREUB-LE6002016-09-12
00872237005192GLOBAL HEALTHCARE81-0012016-09-12
00872237005208GLOBAL HEALTHCARE81-0022016-09-12
00872237008674GLOBAL HEALTHCARE81-003A2016-09-12
00872237008681GLOBAL HEALTHCARE81-004A2016-09-12
00872237008698GLOBAL HEALTHCARE81-005A2016-09-12
00872237008711GLOBAL HEALTHCARE81-007A2016-09-12
00872237009114GLOBAL HEALTHCARE07-21M 2020-08-04
00872237009121GLOBAL HEALTHCARE07-21L2020-08-04
00872237009138GLOBAL HEALTHCARE07-21XL2020-08-04
00872237004263GLOBAL HEALTHCAREUB-PC2016-09-12
00872237004270GLOBAL HEALTHCAREUB-RC2016-09-12
00872237004751GLOBAL HEALTHCAREUB-P2016-09-12
00872237005109GLOBAL HEALTHCARE60-T1652017-02-10

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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