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Pad, Menstrual, Reusable

Page Type
Product Code
Definition
A reusable menstrual pad is made of cellulosic or synthetic material used to absorb menstrual fluid or other vaginal discharge.
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
884.5435
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5435 Unscented menstrual pad

§ 884.5435 Unscented menstrual pad.

(a) Identification. An unscented menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. This generic type of device includes sterile unscented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9 only when the device is made of common cellulosic and synthetic material with an established safety profile.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 67714, Dec. 24, 1996; 65 FR 2320, Jan. 14, 2000; 73 FR 34860, June 19, 2008; 84 FR 71816, Dec. 30, 2019]

Pad, Menstrual, Reusable

Page Type
Product Code
Definition
A reusable menstrual pad is made of cellulosic or synthetic material used to absorb menstrual fluid or other vaginal discharge.
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
884.5435
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5435 Unscented menstrual pad

§ 884.5435 Unscented menstrual pad.

(a) Identification. An unscented menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. This generic type of device includes sterile unscented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9 only when the device is made of common cellulosic and synthetic material with an established safety profile.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 67714, Dec. 24, 1996; 65 FR 2320, Jan. 14, 2000; 73 FR 34860, June 19, 2008; 84 FR 71816, Dec. 30, 2019]