Chrysalis Intelligence · Product Codes · HIS

HIS · Condom

Obstetrics/Gynecology · 27 clearances · 13 unique sponsors

Device class
Class II
Regulation 884.5300
Total clearances
27
2020-07-24 → 2026-05-04
Last 12 months
2
Unique sponsors
13
Medical specialty
Obstetrics/Gynecology
Review panel
OB
Regulation number
884.5300
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Rb Health (Us), LLC 5 0 2022-11-07
Ttk Healthcare Limited 3 0 2023-09-07
Okamoto USA, Inc. 3 1 2026-05-04
Church & Dwight Co., Inc. 3 0 2025-02-21
Suretex Limited 3 1 2025-11-18
Global Protection Corp. 2 0 2021-09-03
Thai Nippon Rubber Industry Public Company Limited. 2 0 2021-09-30
Titan Condoms, LLC 1 0 2022-02-17
Shanghai Personage Hygiene Products Co., Ltd. 1 0 2022-08-05
Shaoguan Regenex Pharmaceuticals Co., Ltd. 1 0 2025-07-11
Lelo, Inc. 1 0 2025-03-07
Suzhou Colour-Way New Material Co., Ltd. 1 0 2022-11-28
Cupid Limited 1 0 2020-08-07
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
A4267 HCPCS Contraceptive supply, condom, male, each ✓ CMS-verified description High HCPCS code for condom, any type
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-04 K252622 Okamoto USA, Inc. Male Latex Condom HA
2025-11-18 K252521 Suretex Limited LifeStyles® HydraFeel Natural Rubber Latex Condom
2025-07-11 K250034 Shaoguan Regenex Pharmaceuticals Co., Ltd. Natural rubber latex male condom
2025-03-07 K243421 Lelo, Inc. Lelo Hex Lubricated Natural Rubber Latex Condom
2025-02-21 K243640 Church & Dwight Co., Inc. Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)
2025-02-18 K243584 Okamoto USA, Inc. 0.04 ZERO ZERO FOUR Male Latex Condom
2023-10-05 K232279 Suretex Limited LifeStyles NRL Textured Condom
2023-09-07 K230049 Ttk Healthcare Limited 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
2022-11-28 K222611 Suzhou Colour-Way New Material Co., Ltd. Male Latex Condoms
2022-11-07 K220489 Rb Health (Us), LLC Durex Patronus CloseFit, Durex Patronus Regular
2022-10-12 K222068 Rb Health (Us), LLC Durex Penck III Regular
2022-09-28 K221906 Church & Dwight Co., Inc. TROJAN Fire & Ice lubricated male natural rubber latex condom
2022-08-05 K220576 Shanghai Personage Hygiene Products Co., Ltd. FAMA Male Latex Condoms
2022-07-14 K221431 Church & Dwight Co., Inc. TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant
2022-05-11 K211152 Rb Health (Us), LLC Durex Condom with Benzocaine
2022-04-28 K213921 Suretex Limited Microthin Natural Rubber Latex Condom
2022-02-17 K213647 Rb Health (Us), LLC Durex Patronus Wide
2022-02-17 K210208 Titan Condoms, LLC Titan Condoms
2021-12-23 K213547 Ttk Healthcare Limited SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla
2021-09-30 K211450 Thai Nippon Rubber Industry Public Company Limited. Playboy 3 Contour Condom
2021-09-23 K210294 Thai Nippon Rubber Industry Public Company Limited. One Touch Spiral Condom
2021-09-03 K203536 Global Protection Corp. Male Latex Condom
2021-04-15 K202403 Ttk Healthcare Limited SKORE (Colors & Flavors), SKORE (Colors)
2020-11-06 K200672 Rb Health (Us), LLC Durex Penck Standard, Durex Penck XL
2020-08-20 K193578 Global Protection Corp. Non-spermicidal Lubricated Male Latex Condom