Data / Medical devices / Thailand / Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd.
Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd.: FDA-registered device maker in Bangplee Samut Prakan, Thailand, 16 510(k) clearances
Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd. is registered with the FDA (registration 3010164364) in Bangplee Samut Prakan, Thailand. It lists 2 device types. The FDA files 16 510(k) clearances under its listings, the newest dated March 7, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010164364
- FEI number
- 3008264702
- Address
- 65 Moo 12 Lardkrabang-Bangplee Rd., Bangplee-Yai, Bangplee Samut Prakan, Thailand, 10540
- Owner or operator
- Reckitt Benckiser LLC (9004884)
- Roles
- Manufacturer
- First device listed
- November 17, 2010
- 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 Cheeky Play Silicone Long Lasting Personal Lubricant, Durex Cheeky Play Silicone Long Lasting Pleasure Personal Lubricant, Durex Juicy Play Cherry Flavored Personal Lubricant, Durex Juicy Play Cherry Flavored Sweeten Up Your Play Personal Lubricant, Durex Massage Lube & Gel Aloe Vera Personal Lubricant and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Patient | KMJ | 1 | Manufacturer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | 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 |
|---|---|---|---|---|---|---|
| March 7, 2023 | K213892 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine | NUC | 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 |
| 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 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
Updated March 7, 2023. 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.