FDA.reportPublic FDA data

SureCare

Primary DI
90834515000667
Brand
SureCare
Company
Ims, Inc.
Model
Powder Free Blue Nitrile, Extended Cuff, XX-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
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00834515000664PrimaryGS10
90834515000667Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00834515000664008345150006648345150006640834515000664
9083451500066790834515000667

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
939727400
Device count
90
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
10850061371246American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371260American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371284American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371291American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371307American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371314American Health and SafetyLabsource, Inc.QDO2026-11-02
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00850069531195Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531065Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531133Maxter BlueMaxter Healthcare IncorporatedQDO2026-10-15
00850069531140Maxter BlueMaxter Healthcare IncorporatedQDO2026-10-15