Consulting Wallah › Device Explorer › Other devices › Basic male condom, Hevea-latex
Device Explorer · FDA GUDID · GMDN 45138

Basic male condom, Hevea-latex

A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or co

US‑registered devices1,604in commercial distribution
Companies40labelers on GUDID
Single‑use99%of device records
Sterile4%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Global Protection Corp.75047%
Suretex Limited - Branch17611%
Church & Dwight Co., Inc.1429%
Lunamax Llc724%
Mayer Laboratories, Inc.342%
Rb Health (Us) Llc332%
Okamoto Usa, Inc.322%
Richter Rubber Technology Sdn. Bhd.322%

Top labelers

CompanyDevicesShare
Global Protection Corp.75047%
Suretex Limited - Branch17611%
Church & Dwight Co., Inc.1429%
Lunamax Llc724%
Mayer Laboratories, Inc.342%
Rb Health (Us) Llc332%
Okamoto Usa, Inc.322%
Richter Rubber Technology Sdn. Bhd.322%
Ttk Healthcare Limited322%
Paradise Marketing Services, A California Corporation312%
Suzhou Colourway New Material Co., Ltd.302%
Shanghai Personage Hygiene Products Co.,Ltd.252%

Company = labeler of record on GUDID. 40 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HEX Condoms Original 72 Pack (US_TNR)HEX Condoms Respect 36 Pack (US_TNR)HEX Condoms Respect 12 Pack (US_TNR)LELO HEX RE-ENGINEERED LATEX RESPECT CONDOM - 6 HEX Condoms Respect 3 Pack (US_FR_TNR) EuroslotHEX Condoms Original 36 Pack (US_TNR)LELO HEX RE-ENGINEERED LATEX CONDOM ORIGINAL - 6HEX Condoms Original 12 Pack (US_TNR)HEX Condoms Original 3 Pack (US_TNR)ZIOXXZl0XX(003) Natural Rubber Latex Male CondomZIOXX Natural Rubber Latex Male CondomMale Latex CondomsFAMA Male Latex CondomsAowawoGETANE

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
HISCondom1,525
HISCONDOM256
NUCLubricant, Personal18
QRZExternal Condom For Anal Intercourse Or Vaginal Intercourse10
MSCBarrier, Std, Oral Sex2
MOLCondom, Synthetic1

GMDN & GCC registration

  • GMDN code 45138 · non‑implantable
  • Single‑use 99% · sterile 4% · Rx‑only 0% · OTC 69%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Millimeter) · 22Length (Millimeter) · 21

Use these as the dimensions to specify in a tender line.

How many basic male condom, hevea-latex products are registered in the US?

1,604 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Basic male condom, Hevea-latex", from 40 companies. The largest labeler is Global Protection Corp. with 47% of records.

Which FDA product codes apply?

HIS (Condom), HIS (CONDOM), NUC (Lubricant, Personal), QRZ (External Condom For Anal Intercourse Or Vaginal Intercourse)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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