FDA.reportPublic FDA data

Biogel® Diagnostic

Primary DI
05060097937127
Brand
Biogel® Diagnostic
Company
Mölnlycke Health Care AB
Model
30375
Device description
Biogel Diagnostic 7.5 x25 US
Published
2022-10-21
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYYLatex patient examination glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971514000REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVELondon International Group, Inc.1997-10-29LYY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060097937127PackageGS125In Commercial Distribution
05060097937202PackageGS16In Commercial Distribution
05055186413743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060097937127050600979371275060097937127
05060097937202050600979372025060097937202
05055186413743050551864137435055186413743

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+46737733775pedro.lopes@molnlycke.com

Regulatory Flags#

DUNS number
631770658
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333350012946Mepiform®2932112026-10-29
07333350064938Biogel® PI Micro Indicator® Underglove66489702026-10-29
07333350119621Biogel® PI Micro Indicator® System66483702026-10-29
07333350176181Biogel® PI Micro Indicator® Underglove66489602026-10-29
07333350400149Mepiform®2931112026-10-29
07333350407926Biogel® PI Micro Indicator® System66483652026-10-29
07333350581305Biogel® PI Micro Indicator® System66483602026-10-29
07333350600297Mepiform®2934012026-10-29
07333350696177Biogel® PI Micro66485652026-10-29
07333350861582Biogel® PI Micro Indicator® Underglove66489652026-10-29
07333350974121Biogel® PI Micro66485602026-10-29
07333350999124Biogel® PI Micro Indicator® Underglove66489752026-10-29
07333350811372Biogel® PI Micro66485702026-10-20
07333350937461Mepiform®2931992026-10-20
07333350635428Mepiform®2934992026-10-16
07333350898588Mepiform®2932992026-10-16
07333350181475Mölnlycke®Z-Flo™ Fluidized Positioner14005002026-09-22
07333350455873Mölnlycke®Z-Flo™ Fluidized Positioner14005222026-09-22
07333350647292Mölnlycke®Z-Flo™ Fluidized Positioner14005132026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized Positioner14005272026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884389108362CURADMEDLINE INDUSTRIES, INC.LYY2026-10-29
00888277187088CURADMEDLINE INDUSTRIES, INC.LYY2026-10-29
00755676002642mvetADI MedicalLYY2026-10-23
00755676002659mvetADI MedicalLYY2026-10-23
00755676002703mvetADI MedicalLYY2026-10-23
00755676002734mvetADI MedicalLYY2026-10-23
00616784245119SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, AmbidextrousDynarex CorporationLYY2026-10-01
00616784245218SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, AmbidextrousDynarex CorporationLYY2026-10-01
00616784671628SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, AmbidextrouDynarex CorporationLYY2026-09-30
00616784671727SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, AmbidextrousDynarex CorporationLYY2026-09-30
00616784671826SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, AmbidextrousDynarex CorporationLYY2026-09-30
00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, AmbidextrousDynarex CorporationLYY2026-09-30
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