FDA.reportPublic FDA data

SureCare

Primary DI
90834515003149
Brand
SureCare
Company
Ims, Inc.
Model
Powder Free Latex, Extended Cuff, Large
Published
2023-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LYYLatex Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00834515003146PrimaryGS10
90834515003149Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00834515003146008345150031468345150031460834515003146
9083451500314990834515003149

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
939727400
Device count
50
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00834515001210SureCare Powder Free, Black, Synthetic Examination Gloves, 2025-07-25
00834515001227SureCare Powder Free, Black, Synthetic Examination Gloves, 2025-07-25
00834515001234SureCare Powder Free, Black, Synthetic Examination Gloves, 2025-07-25
00834515001241SureCare Powder Free, Black, Synthetic Examination Gloves, 2025-07-25
20834515001214SureCare Powder Free, Black, Synthetic Examination Gloves, 2025-07-25
20834515001221SureCare Powder Free, Black, Synthetic Examination Gloves, 2025-07-25
20834515001238SureCare Powder Free, Black, Synthetic Examination Gloves, 2025-07-25
20834515001245SureCare Powder Free, Black, Synthetic Examination Gloves, 2025-07-25
00834515009117SureCarePowder Free Chloroprene, X-Small2022-11-23
00834515009124SureCarePowder Free Chloroprene, Small2022-11-23
00834515009131SureCarePowder Free Chloroprene, Medium2022-11-23
00834515009148SureCarePowder Free Chloroprene, Large2022-11-23
00834515009155SureCarePowder Free Chloroprene, X-Large2022-11-23
00834515009162SureCarePowder Free Chloroprene, XX-Large2022-11-23
00834515000626SureCarePowder Free Blue Nitrile, Extended Cuff, Small2023-04-20
00834515000633SureCarePowder Free Blue Nitrile, Extended Cuff, Medium2023-04-20
00834515000640SureCarePowder Free Blue Nitrile, Extended Cuff, Large2023-04-20
00834515000657SureCarePowder Free Blue Nitrile, Extended Cuff, X-Large2023-04-20
00834515000664SureCarePowder Free Blue Nitrile, Extended Cuff, XX-Large2023-04-20
00834515003122SureCarePowder Free Latex, Extended Cuff, Small2023-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884389108362CURADMEDLINE INDUSTRIES, INC.LYY2026-10-29
00888277187088CURADMEDLINE INDUSTRIES, INC.LYY2026-10-29
00755676002642mvetADI MedicalLYY2026-10-23
00755676002659mvetADI MedicalLYY2026-10-23
00755676002703mvetADI MedicalLYY2026-10-23
00755676002734mvetADI MedicalLYY2026-10-23
00616784245119SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, AmbidextrousDynarex CorporationLYY2026-10-01
00616784245218SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, AmbidextrousDynarex CorporationLYY2026-10-01
00616784671628SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, AmbidextrouDynarex CorporationLYY2026-09-30
00616784671727SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, AmbidextrousDynarex CorporationLYY2026-09-30
00616784671826SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, AmbidextrousDynarex CorporationLYY2026-09-30
00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, AmbidextrousDynarex CorporationLYY2026-09-30
00021130794461Signature CareBETTER LIVING BRANDS LLCLYY2026-07-16
10850015055871TOUGHGRIP 7 MIL LATEX GLOVES-LULINE, INC.LYY2026-07-14
10850015055888TOUGHGRIP 7 MIL LATEX GLOVES-MULINE, INC.LYY2026-07-14
10850015055895TOUGHGRIP 7 MIL LATEX GLOVES-SULINE, INC.LYY2026-07-14
10850015055901TOUGHGRIP 7 MIL LATEX GLOVES-XULINE, INC.LYY2026-07-14
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LULINE, INC.LYY2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MULINE, INC.LYY2026-07-10
10850015055932EXT CUFF 12 MIL LATEX GLOVES-SULINE, INC.LYY2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XULINE, INC.LYY2026-07-10
10076490456525TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456532TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456549TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456556TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10810141931715VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931722VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931746VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931739VIVIT SupplyVivit Supply LLCLYY2024-05-17
09555002101053AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08