510(k) K213400
- Device
- Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry
- Applicant
- Rb Health (Us)
- 510(k) number
- K213400
- Product code
- NUC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-01
- Date received
- 2021-10-18
- Regulation
- 884.5300
- Classification name
- Lubricant, Personal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lisa Burns
- Address
- 399 Interpace Pkwy. Parsippany NJ US 07054 07054
FDA Registration Numbers#
- 3013770781
- 3029582965
- 3008469990
- 3020512730
- 3012194887
- 3015391081
- 1649690
- 2531449
- 3004737812
- 3011015568
- 3015271338
- 3000220439
- 3014317667
- 3036802562
- 3004569514
- 3010386378
- 3015686320
- 3013961642
- 1063707
- 8021871
- 2513595
- 3010419931
- 3008808138
- 3030155386
- 3017022534
- 1221895
- 1222115
- 3010092818
- 3009482034
- 3013441423
- 3009282298
- 3004089975
- 3040301765
- 2938651
- 3042254987
- 3003446042
- 3019444078
- 3011318803
- 3003887639
- 3031885960
- 3008080893
- 3013474580
- 1831301
- 3009599096
- 2434221
- 3010408703
- 3014665853
- 3010164364
- 3021033518
- 1210513
- 3003631744
- 3022754162
- 8040641
- 3013414814
- 3013395518
- 3012909279
- 3029905133
- 3017732703
- 3040313889
- 3011360380
- 2022474
- 3014759506
- 3003231640
- 3008875046
- 3010165308
- 2025292
- 3019793660
- 2025771
- 3012477715
- 3011630465
- 2020372
- 3004079477
- 3027686087
- 1450238
- 2412672
- 3015272252
- 8020300
- 2124143
- 3007829481
- 3006892202
Source Documents#
Other 510(k) Records For Product Code NUC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | PINKSLIP, LLC | 2026-07-09 |
| K261909 | Plum Vagiceuticals™ Vaginal Moisturizing Suppositories | PCCA, Inc. | 2026-07-06 |
| K254011 | Flow Water-Based Personal Lubricant | LBDO Group, Inc. | 2026-06-22 |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories | 2026-06-11 |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | Hathor Professional Skincare , Ltd. | 2026-06-09 |
| K260068 | pjur NATURE Touch, 100 ml | Pjur Group Luxembourg S.A. | 2026-05-21 |
| K254101 | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | 2026-04-16 |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) | Hudi Pharma Srl | 2026-04-01 |
| K253983 | Water-based lubricant | Guangzhou Haoyimai Trading Co., Ltd. | 2026-03-06 |
| K251011 | Chiavaye Personal Moisturizer | Unipack, LLC | 2025-12-19 |
| K252935 | Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) | Foshan Pingchuang Medical Technology Co., Ltd. | 2025-12-15 |
| K250488 | Cerynë Intimate Care | Ansella Therapeutics | 2025-12-12 |
| K251773 | Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) | Shenzhen Yongquan Medical Devices Co., Ltd. | 2025-09-09 |
| K243972 | Plain Water-based Lubricant | Global Protection Corp. | 2025-08-08 |
| K250142 | Water-based Lubricant | Global Protection Corp. | 2025-08-08 |