510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HHLClass II

Pad, Menstrual, Scented, Scented-Deodorized

21 CFR 884.5425 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HHL is the FDA product code for Pad, Menstrual, Scented, Scented-Deodorized, a class II device type, regulated under 21 CFR 884.5425. FDA's definition for this code reads: "Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b)". As of , FDA records hold 57 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HHL
Device name
Pad, Menstrual, Scented, Scented-Deodorized
FDA definition
Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).
Regulation
21 CFR 884.5425
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
57
Ingested recalls
0

Clearances, product code HHL

By decision year
57 clearances under product code HHL with a decision year between 1976 and 1996, 1983 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code HHL by decision year
YearClearances
19762
19771
19793
19803
19812
19821
198310
19849
19855
19865
19872
19885
19893
19912
19964

Applicants with the most clearances

Product code HHL
Applicants holding the most 510(k) clearances under product code HHL
ApplicantClearances
Tambrands Inc.11
Procter & Gamble Mfg. Co.10
Kimberly-Clark Corporation7
Personal Products Co.6
Int'L Consumer Disposables3
Johnson & Johnson Professionals, Inc.3
Paragon Trade Brands, Inc.3
Procter & Gamble Co.3
Tampax, Inc.3
I.C.D. Industries, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order