| Device Type ID | 3992 |
| Device Name | Condom |
| Regulation Description | Condom. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.5300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HIS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3992 |
| Device | Condom |
| Product Code | HIS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Condom. |
| CFR Regulation Number | 884.5300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANSELL HEALTHCARE PRODUCTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CHURCH & DWIGHT CO., INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CHURCH & DWIGHT CO., INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GUANGZHOU DAMING UNITED RUBBER PRODUCTS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HANKOOK LATEX GONGUP CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOLLENDER SUSTAINABLE BRANDS LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KAREX INDUSTRIES SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
M3 GLOBAL ENTERPRISES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NULATEX SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NULATEX SDN. BHD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OKAMOTO | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OKAMOTO INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PROFILATEX, S.A. DE C.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SEDIC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THEYFIT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZHEJIANG XIANGBAN LATEX PRODUCTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Rupture | 5 |
Cross Reactivity | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Break | 2 |
Inadequate Instructions For Non-Healthcare Professional | 1 |
Device Issue | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 16 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Reckitt Benckiser LLC | II | Feb-23-2017 |