FDA.reportPublic FDA data

SureCare

Primary DI
90834515000636
Brand
SureCare
Company
Ims, Inc.
Model
Powder Free Blue Nitrile, 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
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00834515000633PrimaryGS10
90834515000636Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00834515000633008345150006338345150006330834515000633
9083451500063690834515000636

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
939727400
Device count
100
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
false
No natural rubber latex
true
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
00366975073341BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073358BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073365BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073372BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073389BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
10850061371246American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371260American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371284American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371291American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371307American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371314American Health and SafetyLabsource, Inc.LZA2026-11-02
05060655503450Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503467Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503474Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503481Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655504006Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00755676002529mvetADI MedicalLZA2026-10-23
00755676002550mvetADI MedicalLZA2026-10-23
00755676002581mvetADI MedicalLZA2026-10-23
00755676002611mvetADI MedicalLZA2026-10-23
00755676002765mvetADI MedicalLZA2026-10-23
00755676002796mvetADI MedicalLZA2026-10-23
00755676002826mvetADI MedicalLZA2026-10-23
00755676002857mvetADI MedicalLZA2026-10-23
00755676002994mvetADI MedicalLZA2026-10-23