FDA.reportPublic FDA data

DERMATOUCH

Primary DI
00810169801932
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
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
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093300590
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
D184MYNTGNLG100BLK14MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100PNK1MYNTMynt ProfessionalLZA2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15