FDA.reportPublic FDA data

Biogel Sensor®

Primary DI
05060097933730
Brand
Biogel Sensor®
Company
Mölnlycke Health Care AB
Model
30655
Device description
Biogel Sensor 5.5 x 50 US
Published
2022-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGOSurgeon's gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071700000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071700000BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENTMolnlycke Health Care Us, LLC2007-09-11KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060097933815PackageGS150In Commercial Distribution
05060097933891PackageGS14In Commercial Distribution
05060097933730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060097933815050600979338155060097933815
05060097933891050600979338915060097933891
05060097933730050600979337305060097933730

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical 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 at the surgical site; 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 contamination from microorganisms. 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.

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
631770658
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333350377205Mepore®3319002026-05-23
07333350625993Mepore®3320002026-05-23
07333350050498Mestopore®6651002026-05-06
07333350065126Mepore® Pro6711202026-05-06
07333350436575Mepore® Pro6811402026-05-06
07333350477103Mepore® Pro6713202026-05-06
07333350627041Mepore® Pro6712202026-05-06
07333350862176Mepore® Pro6709202026-05-06
07333350872489Mepore®6715002026-05-06
07333350904104Mestopore®6650002026-05-06
07333350917159Mepore® Pro6710202026-05-06
07333350976712Tubigrip®14362026-05-06
07333350996147Mepore®6709702026-05-06
05060097937790Biogel® PI408552022-10-21
05060097937806Biogel® PI408602022-10-21
05060097937813Biogel® PI408652022-10-21
05060097937820Biogel® PI408702022-10-21
05060097937837Biogel® PI408752022-10-21
05060097937844Biogel® PI408802022-10-21
05060097937851Biogel® PI408852022-10-21

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Primary DI, Brand, Company table
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09001570557452Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
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09001570557971Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
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09001570536723Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536730Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12