FDA.reportPublic FDA data

SureCare

Primary DI
00834515003139
Brand
SureCare
Company
Ims, Inc.
Model
Powder Free Latex, Extended Cuff, Medium
Published
2023-04-20
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
LYYLatex Patient Examination Glove
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00834515003139PrimaryGS10
90834515003132Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00834515003139008345150031398345150031390834515003139
9083451500313290834515003132

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Regulatory Flags#

DUNS number
939727400
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

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
00199536900820BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536000018BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000032BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000049BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000056BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
10304040195038CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195090CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195106CriterionHENRY SCHEIN, INC.LZC2026-07-29
00021130794461Signature CareBETTER LIVING BRANDS LLCLYY2026-07-16
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZC2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZC2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZC2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZC2026-07-14
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.LZC2026-07-10
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LULINE, INC.LYY2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MULINE, INC.LZC2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MULINE, INC.LYY2026-07-10