Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003999964

FEI Number

3003999964

Entity Name

DALIAN LATEX CO LTD

City/State/Country

Dalian Liaoning, CN

Establishment Address

No. 18, Haixing Road,Pulandian District, Dalian Liaoning 116200, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Dalian Latex Co Ltd (Owner Number: 10027528)

Owner / Operator Contact Address

No. 18, Haixing Road,Pulandian District, Dalian, CN-LN 116200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K081413

PMA Number

N/A

All Registered Proprietary Names

SHIELDS KAPEET KAPOOT MALE LATEX CONDOM NACH KODEX TWINLOTUS Trunk NACH Presa Skins Blowdom Plain/Ribbed/Dotted/Rib&Dot/Physical Delay/Comfort,condoms

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2008-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Dalian Latex Co Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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3006799339	Nulatex Sdn. Bhd.	Kluang Johor, MY
3026885377	SHANGHAI PERSONAGE HYGIENE PRODUCTS CO.,LTD.	Shanghai, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003999964. Last updated year: 2026. Please use registration number 3003999964 when referencing this establishment in official correspondence.