PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
FDA 510(k) clearance K120245 · decided 2012-06-21
Clearance details
- K-number
- K120245
- Device name
- PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
- Applicant
- Playtex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-01-27
- Decision date
- 2012-06-21
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- HIL
- Device class
- 2
- Regulation number
- 884.5460
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Playtex
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API,
or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| ONTEX AND OTHERS PROPRIETARY NAMES (K132208) | Ontex Bvba | 2014-04-10 |
| PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS (K132819) | Playtex Manufacturing, Inc. | 2013-10-09 |
| PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD (K111684) | Playtex Manufacturing, Inc. | 2012-02-03 |
| TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED (K081555) | Procter & Gamble Co. | 2008-06-27 |
| PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS (K073662) | Playtex Products, Inc. | 2008-01-17 |
| PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS (K072376) | Playtex Products, Inc. | 2007-12-12 |
| MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS (K070745) | Playtex Products, Inc. | 2007-04-13 |
| PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS (K060981) | Playtex Products, Inc. | 2006-05-09 |
| FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS (K051446) | First Quality Hygienic, Inc. | 2005-07-14 |
| FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS (K050067) | First Quality Hygienic, Inc. | 2005-02-01 |
| ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS (K042773) | Rostam , Ltd. | 2004-11-23 |
| TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS (K040312) | Procter & Gamble Co. | 2004-05-03 |
Recalls involving this device
No recalls on record reference this clearance.