510(k) K070937
- Device
- MULTIPLE BRAND MALE LATEX CONDOM
- Applicant
- Nulatex Sdn. Bhd.
- 510(k) number
- K070937
- Product code
- HIS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-09-21
- Date received
- 2007-04-04
- Regulation
- 884.5300
- Classification name
- Condom
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- KIM L LEE
- Address
- Lot 1870, 4th Miles Jalan Mengkibol Kluang, Johor MY 86000 86000
FDA Registration Numbers#
- 8040211
- 9613994
- 2531449
- 3011015568
- 3015436035
- 3008062466
- 3013770781
- 2280705
- 9616578
- 2029275
- 3012909279
- 3010220595
- 9680394
- 2020372
- 3026885377
- 1718873
- 3038641388
- 3039878168
- 1043214
- 3007829481
- 2320762
- 3008559248
- 3003370588
- 2086832
- 9616559
- 3004819929
- 8043142
- 3006799339
- 9616515
- 3003071219
- 9610410
- 9680135
- 8040641
- 1122329
- 1055236
- 3006317264
- 3008808138
- 3006122980
- 3005191252
- 1000136042
- 1010604
- 3007671445
- 3015271338
- 9612266
- 3003759643
- 2025771
- 2938651
- 3003169402
- 3013395518
- 3024836857
- 3029779
- 3004785585
- 3003491851
- 3003902978
- 1222115
- 2084177
- 3042262517
- 8030344
- 3006140792
- 3010599708
- 3005858760
- 3013408180
- 9613932
- 3003963141
- 3007307589
- 1054241
- 2412672
- 8044081
- 3003592318
- 3002997683
- 2025773
- 3015729142
- 9611836
- 3013986076
- 3003823186
- 3003999964
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HIS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252622 | Male Latex Condom HA | Okamoto USA, Inc. | 2026-05-04 |
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | Suretex Limited | 2025-11-18 |
| K250034 | Natural rubber latex male condom | Shaoguan Regenex Pharmaceuticals Co., Ltd. | 2025-07-11 |
| K243421 | Lelo Hex Lubricated Natural Rubber Latex Condom | Lelo, Inc. | 2025-03-07 |
| K243640 | Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) | Church & Dwight Co., Inc. | 2025-02-21 |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | Okamoto USA, Inc. | 2025-02-18 |
| K232279 | LifeStyles NRL Textured Condom | Suretex Limited | 2023-10-05 |
| K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT | Ttk Healthcare Limited | 2023-09-07 |
| K222611 | Male Latex Condoms | Suzhou Colour-Way New Material Co., Ltd. | 2022-11-28 |
| K220489 | Durex Patronus CloseFit, Durex Patronus Regular | Rb Health (Us), LLC | 2022-11-07 |
| K222068 | Durex Penck III Regular | Rb Health (Us), LLC | 2022-10-12 |
| K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condom | Church & Dwight Co., Inc. | 2022-09-28 |
| K220576 | FAMA Male Latex Condoms | Shanghai Personage Hygiene Products Co., Ltd. | 2022-08-05 |
| K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant | Church & Dwight Co., Inc. | 2022-07-14 |
| K211152 | Durex Condom with Benzocaine | Rb Health (Us), LLC | 2022-05-11 |