FDA.reportPublic FDA data

Rampage

Primary DI
00811114030995
Brand
Rampage
Company
Unisafe Inc.
Model
RPA500M
Device description
Powder-Free Latex Examination Gloves
Published
2022-07-29
Public version status
Update
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811114031039PackageGS110In Commercial Distribution
00811114030995PrimaryGS10
10811114030992Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811114031039008111140310398111140310390811114031039
00811114030995008111140309958111140309950811114030995
1081111403099210811114030992

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
080171627
Device count
50
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811114031602ProglovePGV500M2026-05-21
00811114031596ProglovePGV500S2026-05-20
00811114031619ProglovePGV500L2026-05-20
00811114031626ProglovePGV500XL2026-05-20
00811114031930MilgloveN5SM2025-04-11
00811114031947MilgloveN5MD2025-04-11
00811114031954MilGloveN5LG2025-04-11
00811114031961MilgloveN5XL2025-04-11
00811114031978MilgloveN5XXL2025-04-11
00811114031985MilgloveN5SM2025-04-11
00811114032029MilgloveN5MD2025-04-11
00811114031992MilGloveN5LG2025-04-11
00811114032005MilgloveN5XL2025-04-11
00811114032012MilgloveN5XXL2025-04-11
00811114030605Black PythonPY700S2023-07-31
00811114030612Black PythonPY700M2023-07-31
00811114030629Black PythonPY700L2023-07-31
00811114030636Black PythonPY700XL2023-07-31
00811114030704CopperheadCH500S2023-07-31
00811114030735CopperheadCH500L2023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
09555002101060AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101077AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101084AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101091AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101404AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101411AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101428AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101435AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101442AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101558AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101565AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101572AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08