Panels › Obstetrics/Gynecology › Product code MOL · Class 2
Condom, Synthetic
Regulation 884.5300
1510(k)s in 12 months (23 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in MOL
| Company | 510(k)s | Recalls |
|---|---|---|
| Church & Dwight Co., Inc. | 4 | 0 |
| Reckitt Benckiser LLC | 0 | 4 |
| Ansell Healthcare Products, LLC | 3 | 0 |
| Carter Products | 2 | 0 |
| Global Protection Corp. | 2 | 0 |
| Mayer Laboratories | 2 | 0 |
| Sensicon Corp. | 2 | 0 |
| Suretex Limited | 2 | 0 |
| Apex Medical Technologies, Inc. | 1 | 0 |
| Family Dollar Stores, Llc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2022 | Family Dollar Stores, Llc. SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409
LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794
SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415 Open, Classified |
MOL | K160399 |
| Mar 9, 2019 | Reckitt Benckiser LLC Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00
02340-98729-00
02340-98729-00
02340-98729-00
02340-98729-00
02340-98729-00 Terminated |
MOL | K072169 |
| Mar 9, 2019 | Reckitt Benckiser LLC Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14
02340-89455-00
02340-89456-14
02340-89456-14
02340-89455-00
02340-95767-00
02340-89456-14
02340-89457-00
02340-89456-14
02340-894 Terminated |
MOL | K072169 |
| Aug 6, 2018 | Reckitt Benckiser LLC Polyisoprene condomns
Product Usage:
The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually t Terminated |
MOL | K072169 |
| Jul 23, 2018 | Reckitt Benckiser LLC Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00
Product Usage:
The Durex Synthetic polyisoprene male condom is used for contraception and fo Terminated |
MOL | K072169 |
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