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Pad, Menstrual, Scented

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
884.5425
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5425 Scented or scented deodorized menstrual pad

§ 884.5425 Scented or scented deodorized menstrual pad.

(a) Identification. A scented or scented deodorized 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. 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.

(b) Classification. (1) Class I (general controls) for menstrual pads made of common cellulosic and synthetic material with an established safety profile. The devices subject to this paragraph (b)(1) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9. This exemption does not include the intralabial pads and reusable menstrual pads.

(2) Class II (special controls) for scented or scented deodorized menstrual pads made of materials not described in paragraph (b)(1). 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.

[45 FR 12684, Feb. 26, 1980, as amended at 45 FR 51185, Aug. 1, 1980; 61 FR 67714, Dec. 24, 1996; 66 FR 38809, July 25, 2001; 84 FR 71816, Dec. 30, 2019]

Pad, Menstrual, Scented

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
884.5425
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5425 Scented or scented deodorized menstrual pad

§ 884.5425 Scented or scented deodorized menstrual pad.

(a) Identification. A scented or scented deodorized 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. 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.

(b) Classification. (1) Class I (general controls) for menstrual pads made of common cellulosic and synthetic material with an established safety profile. The devices subject to this paragraph (b)(1) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9. This exemption does not include the intralabial pads and reusable menstrual pads.

(2) Class II (special controls) for scented or scented deodorized menstrual pads made of materials not described in paragraph (b)(1). 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.

[45 FR 12684, Feb. 26, 1980, as amended at 45 FR 51185, Aug. 1, 1980; 61 FR 67714, Dec. 24, 1996; 66 FR 38809, July 25, 2001; 84 FR 71816, Dec. 30, 2019]