Data / Medical devices / Thailand / SSL Manufacturing (thailand) Ltd.
SSL Manufacturing (thailand) Ltd.: FDA-registered device maker in BANGSAMAK,BANGPAKONG Chachoengsao, Thailand, 22 510(k) clearances
SSL Manufacturing (thailand) Ltd. is registered with the FDA (registration 3003071219) in BANGSAMAK,BANGPAKONG Chachoengsao, Thailand. It lists 5 device types. The FDA files 22 510(k) clearances under its listings, the newest dated February 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003071219
- Address
- Wellgrow Industrial Estate 100 Moo 5, Bangna-Trad KM 36, BANGSAMAK,BANGPAKONG Chachoengsao, Thailand, 24180
- Owner or operator
- Reckitt Benckiser LLC (9004884)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 23, 2007
- Registered through
- 2026
- Brand names listed
- Durex 2 in 1 Massage Play Aloe Vera, Durex 2 in 1 Massage Play Guarana, Durex 2 in 1 Massage Play Ylang Ylang, Durex Adventure Pack, Durex Air Close Fit, Durex Air Regular Fit, Durex Cheeky Play Silicone Long Lasting Personal Lubricant, Durex Cheeky Play Silicone Long Lasting Pleasure Personal Lubricant and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Condom, Synthetic | MOL | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Device, External Penile Rigidity | LKY | 2 | Specification developer | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Specification developer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 28, 2025 | K241617 | Durex Polyisoprene Condom | MOL | Substantially Equivalent | Rb Health (Us), LLC | accessdata.fda.gov |
| November 7, 2022 | K220489 | Durex Patronus CloseFit, Durex Patronus Regular | HIS | Substantially Equivalent | Rb Health (Us), LLC | accessdata.fda.gov |
| October 12, 2022 | K222068 | Durex Penck III Regular | HIS | Substantially Equivalent | Rb Health (Us), LLC | accessdata.fda.gov |
| May 11, 2022 | K211152 | Durex Condom with Benzocaine | HIS | Substantially Equivalent | Rb Health (Us), LLC | accessdata.fda.gov |
| March 1, 2022 | K213400 | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry | NUC | Substantially Equivalent | Rb Health (Us) | accessdata.fda.gov |
| July 9, 2021 | K211088 | Grosz Play Feel | NUC | Substantially Equivalent | Rb Health (Us), LLC | accessdata.fda.gov |
| July 30, 2020 | K201186 | KY Grosz Jelly | NUC | Substantially Equivalent | Rb Health (Us), LLC | accessdata.fda.gov |
| April 20, 2020 | K193032 | KY Grosz Liquid | NUC | Substantially Equivalent | Rb Health (Us), LLC | accessdata.fda.gov |
| April 14, 2020 | K192982 | KY Grosz UltraGel | NUC | Substantially Equivalent | Rb Health (Us), LLC | accessdata.fda.gov |
| May 17, 2019 | K183505 | KY Banksy Moisture | NUC | Substantially Equivalent | Rb Health (Us), LLC | accessdata.fda.gov |
| April 16, 2019 | K183302 | KY Banksy Aloe | NUC | Substantially Equivalent | Rb Health (Us), LLC | accessdata.fda.gov |
| January 12, 2018 | K173504 | K-Y Silicone | NUC | Substantially Equivalent | Reckitt Benckiser, LLC | accessdata.fda.gov |
| January 11, 2016 | K151884 | K-Y Marilyn Pleasure Gel | NUC | Substantially Equivalent | Reckitt Benckiser, LLC | accessdata.fda.gov |
| November 8, 2013 | K122061 | K-Y BRAND LIQUIBEADS | NUC | Substantially Equivalent | Johnson & Johnson Healthcare Products | accessdata.fda.gov |
| June 19, 2008 | K072169 | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM | MOL | Substantially Equivalent | Ssl Americas, Inc. | accessdata.fda.gov |
| May 7, 2008 | K072236 | DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT | NUC | Substantially Equivalent | Ssl Americas | accessdata.fda.gov |
| March 10, 2008 | K063385 | DUREX PLAY MASSAGE GEL LUBRICANT | NUC | Substantially Equivalent | Ssl Americas, Inc. | accessdata.fda.gov |
| March 6, 2008 | K072421 | K-Y BRAND YOURS+MINE | NUC | Substantially Equivalent | Mcneil-Ppc, Inc. | accessdata.fda.gov |
| March 23, 2007 | K070545 | K-Y BRAND WARMING LIQUID | NUC | Substantially Equivalent | Personal Products Co. | accessdata.fda.gov |
| February 23, 2005 | K042563 | DUREX PLAY WARMER LUBRICANT | KMJ | Substantially Equivalent | Ssl Americas, Inc. | accessdata.fda.gov |
| April 27, 2004 | K040185 | DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM | HIS | Substantially Equivalent | Ssl Americas | accessdata.fda.gov |
| April 5, 2004 | K040164 | K-Y BRAND WARMING JELLY PERSONAL LUBRICANT | NUC | Substantially Equivalent | Personal Products Company, Div. of Mcneil-Ppc, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Condom
- All makers of Condom, Synthetic
- All makers of Lubricant, Patient
- All makers of Lubricant, Personal
- All makers of Device, External Penile Rigidity
Updated February 28, 2025. 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.