Atlas FDA

TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED

FDA 510(k) clearance K081555 · decided 2008-06-27

Clearance details

K-number
K081555
Device name
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
Applicant
Procter & Gamble Co.
Decision
Substantially Equivalent
Date received
2008-06-03
Decision date
2008-06-27
Days to decision
24 days
Clearance type
Special
Product code
HIL
Device class
2
Regulation number
884.5460
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Cincinnati, OH, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ONTEX AND OTHERS PROPRIETARY NAMES (K132208)Ontex Bvba2014-04-10
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS (K132819)Playtex Manufacturing, Inc.2013-10-09
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS (K120245)Playtex, Inc.2012-06-21
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD (K111684)Playtex Manufacturing, Inc.2012-02-03
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

RecordFirmDate
Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINER recall (Z-1182-2026)GOLD STAR DISTRIBUTION INC2026-01-27