Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025355668

FEI Number

3025355668

Entity Name

Molnlycke Health Care SDN BHD

City/State/Country

Kulim Kedah, MY

Establishment Address

Lot 12A, Jalan Hi-Tech 7, Industrial Zone Phase 2, Kulim Hi-Tech Park, Kulim Kedah 09090, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MOLNLYCKE HEALTH CARE US LLC (Owner Number: 8030877)

Owner / Operator Contact Address

5445 Triangle Parkway, Suite 400, Peachtree Corners, GA 30092, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190077

PMA Number

N/A

All Registered Proprietary Names

Biogel Eclipse Biogel Skinsense N Biogel NeoDerm Biogel Skinsense Indicator Underglove BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Biogel Super-Sensitive surgical glove Biogel Sensor Glove Biogel Opti-Fit Ortho surgical gloves Biogel PI OrthoPro Biogel Skinsense Biogel PI surgical glove Biogel PI Pro-Fit surgical glove Biogel PI UltraTouch M surgical glove Biogel PI Ultratouch G surgical glove Biogel PI UltraTouch surgical glove Biogel PI UltraTouch S Indicator Underglove Biogel PI UltraTouch S Surgical Glove

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2012-02-06
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2019-09-25

Official Correspondent

Yannick Spenninck

US Agent Details

Yannick Spenninck Business: MOLNLYCKE HEALTH CARE US LLC Email: yannick.spenninck@molnlycke.com Phone: (470) 3903565

Related Public Records

Same Entity

MOLNLYCKE HEALTH CARE US LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006607005	MOLNLYCKE HEALTH CARE (THAILAND), LTD.	Amphur Muang Chonburi Chon Buri, TH
1225263	Molnlycke Manufacturing US, LLC	Wiscasset, ME, US
3010099071	MOLNLYCKE MANUFACTURING US, LLC	Brunswick, ME, US
3010309112	Molnlycke Health Care Sdn. Bhd.	Kuala Ketil Kedah, MY
3007048057	Molnlycke Health Care AB	Molndal Vastra Gotaland, SE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02

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3025413681	GUILIN HUADA BIOTECHNOLOGY CO., LTD.	Guilin City Guangxi, CN
8041005	WRP ASIA PACIFIC SDN. BHD.	SALAK TINGGI, SEPANG Selangor, MY
3004122598	PRODUCTOS MEDLINE S.A. DE C.V.	NUEVO LAREDO Tamaulipas, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025355668. Last updated year: 2026. Please use registration number 3025355668 when referencing this establishment in official correspondence.