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

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile 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 patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

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
20680651500674HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500681HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500698HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500704HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500711HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502388HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502395HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502401HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502418HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502425HalyardO&M HALYARD, INC.QDO2026-06-04
10810141933740VIVIT SupplyVivit Supply LLCQDO2026-02-03
10810141933757VIVIT SupplyVivit Supply LLCQDO2026-02-03
10810141933764VIVIT SupplyVivit Supply LLCQDO2026-02-03
10810141933771VIVIT SupplyVivit Supply LLCQDO2026-02-03
10810141933788VIVIT SupplyVivit Supply LLCQDO2026-02-03
10076490788657MICROFLEXAnsell Healthcare ProductQDO2025-08-05
10076490788664MICROFLEX Ansell Healthcare ProductQDO2025-08-05
10076490788671MICROFLEXAnsell Healthcare ProductQDO2025-08-05
10076490788688MICROFLEXAnsell Healthcare ProductQDO2025-08-05
10076490788695MICROFLEXAnsell Healthcare ProductQDO2025-08-05
10076490708495KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490714397KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490716568KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490723740KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490737334KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490711426KIMTECHAnsell Healthcare ProductQDO2025-07-03
10076490735903KIMTECHAnsell Healthcare ProductQDO2025-07-03
10076490737518KIMTECHAnsell Healthcare ProductQDO2025-07-03
10076490744004KIMTECHAnsell Healthcare ProductQDO2025-07-03
10076490750999KIMTECHAnsell Healthcare ProductQDO2025-07-03