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510(k) Data Aggregation
K Number
K071827Device Name
ALWAYS MENSTRUAL PADS
Manufacturer
Date Cleared
2007-09-20
(79 days)
Product Code
Regulation Number
884.5435Why did this record match?
Product Code :
HHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Always® are unscented menstrual pads for absorption of menstrual and other vaginal discharge, and for absorption of urine loss associated with light incontinence due to stress-related activities such as laughs, coughs, sneezes and exercise.
Device Description
The menstrual pad device has 4 primary components, 1) The permeable topsheet allows fluid to pass through into the core; 2) the absorbent core acquires and stores fluid; 3) the impermeable backsheet prevents fluid transfer beyond the core; 4) the attachment adhesive holds the pad in place, The absorbent core is held in place between the topsheet and the backsheet.
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K Number
K012629Device Name
ALWAYS DUETS
Manufacturer
Date Cleared
2001-10-05
(53 days)
Product Code
Regulation Number
884.5435Why did this record match?
Product Code :
HHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The P&G Miniform #3 Unscented Interlabial Menstrual Pad can be worn any time of the day or night in the following ways:
- Alone for light and medium (menstrual) flow .
- In combination with tampons or pads for extra protection during heavy . (menstrual) flow
- Alone for vaginal discharge or slight urine loss associated with laughs, . coughs, and sneezes.
The P&G Unscented Menstrual Pad can be worn any time of the day or night in the following ways:
- For menstrual flow or other vaginal discharge .
Device Description
The interlabial pad device has 3 primary components:
- 1. The permeable topsheet allows fluid to pass through into the core.
- 2. The absorbent core acquires and stores the fluid.
- 3. The impermeable backsheet prevents fluid transfer beyond the core.
The absorbent core is held in place between the topsheet and backsheet, which are bonded at the perimeter to form an ellipse-shaped trilaminate structure. An attached tab glued onto the backsheet extends from the back of the device as an aid for application and removal.
The device will be individually wrapped and packaged in sealed multi-unit containers for retail sale.
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K Number
K003843Device Name
ENVIVE MINIFORMS
Manufacturer
Date Cleared
2001-02-08
(58 days)
Product Code
Regulation Number
884.5435Why did this record match?
Product Code :
HHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K993870Device Name
UNSCENTED INTERLABIAL MENSTRUAL PAD
Manufacturer
Date Cleared
2000-01-18
(64 days)
Product Code
Regulation Number
884.5435Why did this record match?
Product Code :
HHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Unscented Interiabial Menstrual Pad can be wom any time of the day or night in the following ways: Alone for light and medium (menstrual) flow; In combination with tampons or pads for extra protection during heavy (menstrual) flow; Alone for vaginal discharge or slight urine loss associated with laughs, coughs, and sneezes.
Device Description
The device has 3 primary components: 1. The permeable topsheet allows fluid to pass through into the core. 2. The absorbent core acquires and stores the fluid. 3. The impermeable backsheet prevents fluid transfer beyond the core. The absorbent core is held in place between the topsheet and backshoet, which are bonded at the perimeter to form an ovoid trilaminate structure. A tab formed from the backsheet extends from the back of the device as an aid for application and removal, The device will be individually wrapped and packaged in sealed multi-unit containers for retail sale,
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K Number
K980395Device Name
GLADRAGS COTTON MENSTRUAL PAD
Manufacturer
Date Cleared
1998-04-16
(73 days)
Product Code
Regulation Number
884.5435Why did this record match?
Product Code :
HHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GladRags Cotton Menstrual Pads are washable and reusable. They are meant for personal use (use by only one person) to collect menstrual flow and are designed for external use.
Device Description
GladRags Cotton Menstrual Pads
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