FDA.reportPublic FDA data

Chongjen

Primary DI
06974681690550
Brand
Chongjen
Company
SHANGHAI CHONGJEN INDUSTRY CO., LTD.
Model
LDPE Gloves,M
Published
2023-01-18
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
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974681690550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974681690550069746816905506974681690550

GMDN Terms#

Term, Definition table
TermDefinition
Assistive glove/mittenA garment specially designed/adapted to be worn on the hand(s) of a person with a disability to function as a protective barrier between the user's hand(s) and the external environment, typically to keep the hands warm and dry. It is typically constructed with features that facilitate easy donning, fastening, and removal (e.g., special shape to accommodate a disability, Velcro fasteners).

Regulatory Flags#

DUNS number
560012294
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974681690604ChongjenCPE Gloves,S2023-01-19
06974681690611ChongjenCPE Gloves,M2023-01-19
06974681690628ChongjenCPE Gloves,L2023-01-19
06974681690635ChongjenCPE Gloves,XL2023-01-19
06974681690475ChongjenLab Coat,S2023-01-18
06974681690482ChongjenLab Coat,M2023-01-18
06974681690499ChongjenLab Coat,L2023-01-18
06974681690505ChongjenLab Coat,XL2023-01-18
06974681690512ChongjenLab Coat,XXL2023-01-18
06974681690529ChongjenLab Coat.XXXL2023-01-18
06974681690536ChongjenLab Coat,XXXXL2023-01-18
06974681690567ChongjenLDPE Gloves,L2023-01-18
06974681690574ChongjenHDPE Gloves,M2023-01-18
06974681690581ChongjenHDPE Gloves,L2023-01-18
06974681690598ChongjenHDPE Gloves,XL2023-01-18
06974681690291Chongjen"Bouffant Cap,24"""2023-01-17
06974681690307Chongjen"Mesh Cap,18"""2023-01-17
06974681690314Chongjen"Mesh Cap,21"""2023-01-17
06974681690321Chongjen"Mesh Cap,24"""2023-01-17
06974681690338ChongjenIsolation Gown,S2023-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10097604245002Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
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10097604245200Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245309Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245354Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245408Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245453Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245507Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245552Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956007Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956052Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956106Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956205Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956304Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956359Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956403Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956458Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956502Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956557Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10195327657802Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYU2024-07-29
10097604245064Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245163Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245262Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245361Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245460Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245569Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245668Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245767Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245866Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28