Consulting Wallah › Device Explorer › Other devices › Basic male condom, synthetic polymer
Device Explorer · FDA GUDID · GMDN 34151

Basic male condom, synthetic polymer

A sheath made from synthetic polymers (e.g., polyurethane, polyisoprene) 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 infectio

US‑registered devices245in commercial distribution
Companies10labelers on GUDID
Single‑use100%of device records
Sterile2%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Suretex Limited - Branch19680%
Global Protection Corp.167%
Reckitt Benckiser Llc135%
Church & Dwight Co., Inc.62%
Lunamax Llc42%
Paradise Marketing Services, A California Corporation31%
Lil' Drug Store Products, Inc.31%
Bioseal21%

Top labelers

CompanyDevicesShare
Suretex Limited - Branch19680%
Global Protection Corp.167%
Reckitt Benckiser Llc135%
Church & Dwight Co., Inc.62%
Lunamax Llc42%
Paradise Marketing Services, A California Corporation31%
Lil' Drug Store Products, Inc.31%
Bioseal21%
Mechanical Servants Llc10%
Deroyal Industries, Inc.10%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LifestylesLifeStyles SKYN Large 40 ct BowlLifeStyles SKYN Original 40 ct BowlLifestyles SKYN Elite 40 ct BowlSKYNDeRoyalOne LuxOneBioseal Inc.Durex IntenseDurex Intense Ultra LubeDurex Intense XLDUREX Real Feel Non-Latex CondomSkynLIFESTYLESLIfestyles

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

FDA product codes

CodeNameDevices
MOLCondom, Synthetic223
HISCondom16
MOLCondom, synthetic13
NUCLubricant, Personal4
KDDKit, surgical instrument, disposable2
HISCONDOM1

GMDN & GCC registration

  • GMDN code 34151 · non‑implantable
  • Single‑use 100% · sterile 2% · Rx‑only 0% · OTC 15%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

How many basic male condom, synthetic polymer products are registered in the US?

245 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Basic male condom, synthetic polymer", from 10 companies. The largest labeler is Suretex Limited - Branch with 80% of records.

Which FDA product codes apply?

MOL (Condom, Synthetic), HIS (Condom), MOL (Condom, synthetic), NUC (Lubricant, Personal)

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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