FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS
K Number: K982383
·
Decision Aug 19, 1998
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
83
Applicant Total
17
Review Days
42
Basic Information
- Device Name
- PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS
- K Number
- K982383
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5460
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PLAYTEX PRODUCTS, INC.
- Date Received
- July 8, 1998
- Decision Date
- August 19, 1998
- Product Code
- HIL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIL | Tampon, Menstrual, Scented, Deodorized | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIL), ordered by most recent decision date.
ONTEX AND OTHERS PROPRIETARY NAMES
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PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
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PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
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PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
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TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
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·Obstetrics/Gynecology
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by PLAYTEX PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K073662 | PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS | Jan 17, 2008 | Substantially Equivalent |
| K072376 | PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS | Dec 12, 2007 | Substantially Equivalent |
| K070745 | MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS | Apr 13, 2007 | Substantially Equivalent |
| K061013 | PLAYTEX EMBRACE PETITE BREAST PUMP | Aug 15, 2006 | Substantially Equivalent |
| K060981 | PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS | May 9, 2006 | Substantially Equivalent |
| K032636 | PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED) | Nov 14, 2003 | Substantially Equivalent |
| K022594 | PLAYTEX BREAST PUMP | Nov 1, 2002 | Substantially Equivalent |
| K022882 | MODIFICATION TO PLAYTEX TAMPONS #24002 | Sep 16, 2002 | Substantially Equivalent |
| K020200 | PLAYTEX DEODORANT TAMPONS, MODEL 34802 | Mar 13, 2002 | Substantially Equivalent |
| K020202 | PLAYTEX DEODORANT TAMPONS, MODEL 34702 | Mar 12, 2002 | Substantially Equivalent |