FDA.reportPublic FDA data

DERMATOUCH

Primary DI
00810169801864
Brand
DERMATOUCH
Company
PRIME SOLUTIONS, INC.
Model
81140MD/M
Published
2025-12-15
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
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
00810169801932PackageGS110In Commercial Distribution
00810169801864PrimaryGS10
10810169801861Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810169801932008101698019328101698019320810169801932
00810169801864008101698018648101698018640810169801864
1081016980186110810169801861

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor XI inhibitor IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of coagulation factor XI inhibitor in a clinical specimen.

Regulatory Flags#

DUNS number
093300590
Device count
100

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810169802373DERMATOUCH82235MD/XS2026-04-24
00810169802380DERMATOUCH82235MD/S2026-04-24
00810169802397DERMATOUCH82235MD/M2026-04-24
00810169802403DERMATOUCH82235MD/L2026-04-24
00810169802410DERMATOUCH82235MD/XL2026-04-24
00810169802427DERMATOUCH82235MD/XXL2026-04-24
00810169802199DERMATOUCH81260MD/S2026-02-10
00810169802205DERMATOUCH81260MD/M2026-02-10
00810169802212DERMATOUCH81260MD/L2026-02-10
00810169802229DERMATOUCH81260MD/XL2026-02-10
00810169802236DERMATOUCH81260MD/2XL2026-02-10
00810169802243DERMATOUCH81260MD/S2026-02-10
00810169802250DERMATOUCH81260MD/M2026-02-10
00810169802267DERMATOUCH81260MD/L2026-02-10
00810169802274DERMATOUCH81260MD/XL2026-02-10
00810169802281DERMATOUCH81260MD/2XL2026-02-10
00810169800911DERMATOUCH81150MD/S2025-12-30
00810169800928DERMATOUCH81150MD/M2025-12-30
00810169800935DERMATOUCH81150MD/L2025-12-30
00810169800942DERMATOUCH81150MD/XL2025-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22
00850084857362MedClickMedClick LLCLZA2026-07-22
00850084857379MedClickMedClick LLCLZA2026-07-22
00850084857386MedClickMedClick LLCLZA2026-07-22
00850084857393MedClickMedClick LLCLZA2026-07-22
00850084857409MedClickMedClick LLCLZA2026-07-22
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06