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510(k) Data Aggregation
K Number
K120245Device Name
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
Manufacturer
PLAYTEX, INC.
Date Cleared
2012-06-21
(146 days)
Product Code
HIL, HEB
Regulation Number
884.5460Why did this record match?
Applicant Name (Manufacturer) :
PLAYTEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Playtex® Gentle Glide Scented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Playtex® Gentle Glide Unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow < 6 grams (Slender Light)
Absorbs menstrual flow 6-9 grams (Slender Regular, Regular)
Absorbs menstrual flow 9-12 grams (Super)
Absorbs menstrual flow 12-15 grams (Super Plus)
Absorbs menstrual flow 15-18 grams (Ultra)
Device Description
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
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K Number
K980478Device Name
PLAYTEX TAMPONS #03498
Manufacturer
PLAYTEX, INC.
Date Cleared
1998-04-03
(56 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
PLAYTEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Unscented menstrual tampons for absorption of menstrual fluid.
Device Description
Not Found
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K Number
K971174Device Name
PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS
Manufacturer
PLAYTEX, INC.
Date Cleared
1997-05-21
(51 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
PLAYTEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Unscented menstrual tampons for absorption of menstrual fluid.
Device Description
Unscented menstrual tampons for the absorption of menstrual fluid.
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