Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency
K151470 is the FDA 510(k) clearance record for Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency, a class II device, cleared for First Quality Hygienic, Inc. on under FDA product code HEB (Tampon, Menstrual, Unscented). FDA's definition for product code HEB reads: "An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge". FDA records list 11 510(k) clearances for First Quality Hygienic, Inc., from to . As of , FDA records show no recalls naming K151470.
Clearance record
- Decision date
- Received
- (154 days to decision)
- Product code
- HEB Tampon, Menstrual, Unscented
- Regulation
- 21 CFR 884.5470
- Device class
- Class II
- Review panel
- Obstetrics/Gynecology
- Applicant
- First Quality Hygienic, Inc. 121 N. Rd., Mcelhattan PA
- 510(k) summary
- Summary PDF
- Third party review
- Yes
Clearances, product code HEB
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 1 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 1 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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