FDA.reportPublic FDA data

GSO

Primary DI
16975803530881
Brand
GSO
Company
Group Supply Organization Medical Technology(Shanghai) Ltd
Model
GC01B
Device description
GOWN ISOLATION IMPERVIOUS BLUE
Published
2025-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FMEGown, Examination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26975803530888PackageGS175In Commercial Distribution
16975803530881PrimaryGS10
06975803530884Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697580353088826975803530888
1697580353088116975803530881
06975803530884069758035308846975803530884

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.

Regulatory Flags#

DUNS number
554525912
Device count
15
Premarket exempt
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
16975803530805GSOGCB15LF2025-11-30
16975803530812GSOGCB25LF2025-11-30
16975803530829GSOGCB35LF2025-11-30
16975803530836GSOGCB45LF2025-11-30
16975803530843GSOGCB25LFS2025-11-30
16975803530850GSOGCB45LFS2025-11-30
16975803530867GSOGCB25LFC2025-11-30
26975803530802GSOGCB15LF2025-11-30
26975803530819GSOGCB25LF2025-11-30
26975803530826GSOGCB35LF2025-11-30
26975803530833GSOGCB45LF2025-11-30
26975803530840GSOGCB25LFS2025-11-30
26975803530857GSOGCB45LFS2025-11-30
26975803530864GSOGCB25LFC2025-11-30
16975803530874GSOGCB25LFB2025-11-30
26975803530888GSOGC01B2025-11-30
06975803530594GSOGDTC1840SS2023-03-06
06975803530600GSOGDTC2440SS2023-03-06
06975803530617GSOGDTC3040SS2023-03-06
06975803530624GSOGDTC3440SS2023-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10097604573327Tronex International, Inc.TRONEX INTERNATIONAL, INC.FME2024-12-30
10850053289511SURGYCOSurgyco LLCFME2024-08-09
10850053289559SURGYCOSurgyco LLCFME2024-08-09
10850053289566SURGYCOSurgyco LLCFME2024-08-09
10850053289573SURGYCOSurgyco LLCFME2024-08-09
10850053289740SURGYCOSurgyco LLCFME2024-08-09
10850053289757SURGYCOSurgyco LLCFME2024-08-09
10810141931388VIVIT SupplyVivit Supply LLCFME2024-01-19
10810141931395VIVIT SupplyVivit Supply LLCFME2024-01-19
10850045738065UNCThe University of North Carolina Health SystemFME2023-10-31
10810141930473VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930480VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930497VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930503VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930176VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930183VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930190VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930206VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930213VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930220VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930237VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930244VIVIT SupplyVivit Supply LLCFME2023-09-10
10850044799890SURGYCOSurgyco LLCFME2023-06-30
10850044799906SURGYCOSurgyco LLCFME2023-06-30
10850044799913SURGYCOSurgyco LLCFME2023-06-30
10850044799937SURGYCOSurgyco LLCFME2023-06-30
10850044799944SURGYCOSurgyco LLCFME2023-06-30
20612899005482EncompassEncompass Group, L.L.C.FME2023-06-21
20612899005499EncompassEncompass Group, L.L.C.FME2023-06-21
20612899005505EncompassEncompass Group, L.L.C.FME2023-06-21