A menstrual pad is an absorbent pad made of cellulose or synthetic material that is used to absorb menstrual or other vaginal discharge. It is available in two forms:

1. Scented or scented deodorized menstrual pad
2. Unscented menstrual pad.

Intended Use of Menstrual Pad

The menstrual pad is intended for external use as an absorbent hygiene product designed to absorb menstrual flow (menstrual blood) and other vaginal discharge. It is worn externally (typically in undergarments) to provide hygienic protection, help maintain cleanliness and comfort, and reduce leakage during menstruation. Menstrual pads may be provided as unscented products or as scented/scented-deodorized products, where fragrance may be included for aesthetic or deodorizing purposes.

Intended use:
An unscented menstrual pad, which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.

Device Description:

It is a reusable, unscented menstrual pad made of common cellulosic and/or synthetic absorbent materials with an established safety profile, for external use to absorb menstrual flow and other vaginal discharge. The physical absorption and retention of menstrual fluid within the pad’s absorbent structure, where fluid is drawn into the core by capillary action and retained through fluid entrapment, helps reduce leakage and maintain dryness at the skin-contact surface; the device does not achieve its primary purpose through any pharmacological, metabolic, or therapeutic action.

Pad, Menstrual, Reusable

Intended use:
A reusable, unscented menstrual pad that is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic or synthetic material with an established safety profile.

Device Description:

It is a reusable, unscented menstrual pad made of common cellulosic and/or synthetic absorbent materials with an established safety profile, for external use to absorb menstrual flow and other vaginal discharge. The physical absorption and retention of menstrual fluid within the pad’s absorbent structure, where fluid is drawn into the core by capillary action and retained through fluid entrapment, helps reduce leakage and maintain dryness at the skin-contact surface; the device does not achieve its primary purpose through any pharmacological, metabolic, or therapeutic action.

Pad, Menstrual, Intralabial

Intended use:

An unscented menstrual pad intended as an intralabial pad, which is placed over the vaginal introitus to absorb menstrual fluid or other vaginal discharge, and is made of common cellulosic or synthetic material with an established safety profile.

Device Description:

It is an absorbent menstrual pad made of cellulosic or synthetic material designed to be placed over the vaginal introitus to absorb menstrual fluid or other vaginal discharge. It provides external hygienic protection during menstruation by physically absorbing and retaining menstrual flow through capillary action and fluid entrapment, and the intralabial design helps position and maintain the pad at the vaginal opening to reduce leakage. It does not exert any therapeutic or pharmacological effect beyond fluid absorption.

Pad, Menstrual, Scented, Scented-Deodorized made of Common Cellulosic & Synthetic Material W/Established Safety Profile

Intended use:

A scented or unscented deodorized menstrual pad is a device made of cellulosic or synthetic material used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual pad) or for deodorizing purposes (scented deodorized menstrual pad). This generic type of device includes sterile scented menstrual pads used for medically indicated conditions but does not include menstrual pads treated with added antimicrobial agents or other drugs.

Device Description:

It is a scented or scented-deodorized menstrual pad made of common cellulosic and/or synthetic absorbent materials with an established safety profile, intended for external use to absorb menstrual flow and other vaginal discharge. The physical absorption and retention of menstrual fluid within the pad’s absorbent core, facilitated by capillary action and fluid entrapment, help reduce leakage and maintain dryness at the skin-contact surface. The device may also include added fragrance to provide an aesthetic or deodorizing effect, without contributing to a therapeutic or pharmacological action.

Performance Testing (Analytical) for Menstrual Pad

• Absorbency / Total Fluid Capacity
• Acquisition / Strike-Through Time
• Rewet / wetback
• Leakage Resistance (backsheet + edge)
• Mechanical Integrity (wet + dry strength, tear resistance)
• Adhesive performance (ONLY if pad has adhesive strip/wings)
• Wicking / Fluid Distribution
• Shape Retention (bunching/curling)
• Fragrance Content Uniformity
• Odor Control Performance (ONLY if you claim deodorizing performance)
• Retention / Dislodgement Resistance (movement simulation)
• Placement Stability (slip test)
• Absorbency After Repeated Wash Cycles(Reusable)
• Durability After Wash/Dry Cycles (seams, stitching, delamination_(Reusable))
• Shrinkage / Deformation After Washing(Reusable)
• Colorfastness / Linting (good to include_(Reusable))
• Biocompatibility (Cytotoxicity, Skin irritation, Sensitization)

Clinical Testing:

No Guidance available for 510k submission