Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010309112

FEI Number

3010309112

Entity Name

Molnlycke Health Care Sdn. Bhd.

City/State/Country

Kuala Ketil Kedah, MY

Establishment Address

Plot 204, Kawasan Perindustrian, Kuala Ketil, Kuala Ketil Kedah 09300, 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

K071565

PMA Number

N/A

All Registered Proprietary Names

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

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	2015-12-21
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
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2009-01-13
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
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-04-02
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

Official Correspondent

Yannick Spenninck

US Agent Details

Yannick Spenninck Business: Molnlycke Health Care 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
3007048057	Molnlycke Health Care AB	Molndal Vastra Gotaland, SE
8020673	MOLNLYCKE HEALTH CARE	OLDHAM, GB

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
K894452	Kerala Rubber & Reclaims, Ltd.	KRR GLOVE, PATIENT EXAMINATION GLOVES	1989-08-09
K891323	Li Wah-Hong Kong, Inc.	LI WAH LATEX EXAMINATION GLOVES	1989-08-31
K891418	C & K Mfg. & Sales Co.	LATEX EXAMINATION GLOVES, STYLE 510 LX	1989-06-22

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3012551999	ST.MARYS RUBBERS PVT LTD	Kottayam Kerala, IN
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 3010309112. Last updated year: 2026. Please use registration number 3010309112 when referencing this establishment in official correspondence.