Data / Medical devices / Malaysia / Molnlycke Health Care SDN BHD
Molnlycke Health Care SDN BHD: FDA-registered device maker in KULIM Kedah, Malaysia, 17 510(k) clearances
Molnlycke Health Care SDN BHD is registered with the FDA (registration 9610054) in KULIM Kedah, Malaysia. It lists 2 device types. The FDA files 17 510(k) clearances under its listings, the newest dated May 24, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610054
- FEI number
- 1000207790
- Address
- Lot 9, Lorong Perusahaan 4 Kulim Industrial Estate, KULIM Kedah, Malaysia, 09000
- Owner or operator
- MOLNLYCKE HEALTH CARE US LLC (8030877)
- Roles
- Manufacturer
- First device listed
- April 2, 2008
- Registered through
- 2026
- Brand names listed
- BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS), Biogel Diagnostic, Biogel Eclipse, Biogel Indicator Underglove, Biogel M, Biogel NeoDerm, Biogel Opti-Fit Ortho surgical gloves, Biogel PI Indicator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 24, 2019 | K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| August 31, 2015 | K150146 | Biogel PI Micro Indicator Underglove | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| September 4, 2014 | K141719 | BIOGEL PL MICRO SURGICAL GLOVE | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| September 20, 2011 | K112257 | BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| August 26, 2008 | K081180 | SKINSENSE POLYISOPRENE UNDERGLOVE | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| September 11, 2007 | K071700 | BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| September 11, 2007 | K071465 | BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| September 10, 2007 | K071565 | BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| September 10, 2007 | K071414 | BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| April 10, 2006 | K053441 | BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| March 10, 2006 | K053102 | BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| March 7, 2006 | K053442 | BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| February 1, 2006 | K053443 | BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| August 12, 2005 | K050899 | BIOGEL LATEX STERILE POWDER-FREE GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| March 16, 2005 | K050184 | BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| August 14, 2000 | K000421 | BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE | KGO | Substantially Equivalent | Ssl Americas, Inc. (Regent Medical) | accessdata.fda.gov |
| October 29, 1997 | K971514 | REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE | LYY | Substantially Equivalent | London International Group, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 24, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.