UG HEALTHCARE (USA), INC.

FDA Device Registration & Listing · Costa Mesa, CA, US · Registration 2087418

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2087418
FEI Number
3001133325
Entity Name
UG HEALTHCARE (USA), INC.
City/State/Country
Costa Mesa, CA, US
Establishment Address
1565 Sunflower Avenue, Costa Mesa, CA 92626, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
UG HEALTHCARE (USA), INC. (Owner Number: 9051933)
Owner / Operator Contact Address
1565 Sunflower Avenue, --, Costa Mesa, CA 92626, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K112012
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2015-10-20
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2015-10-19

Official Correspondent

Patrick STANTON

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UG HEALTHCARE (USA), INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K894452 Kerala Rubber & Reclaims, Ltd. KRR GLOVE, PATIENT EXAMINATION GLOVES 1989-08-09
K891323 Li Wah-Hong Kong, Inc. LI WAH LATEX EXAMINATION GLOVES 1989-08-31
K891418 C & K Mfg. & Sales Co. LATEX EXAMINATION GLOVES, STYLE 510 LX 1989-06-22
K994255 Pt. Maja Agung Latexindo LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE 2000-02-07
K892946 Yeou-Fwu Rubber Industrial Co., Ltd. STERILE PATIENT EXAMINATION GLOVES 1989-08-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2087418. Last updated year: 2026. Please use registration number 2087418 when referencing this establishment in official correspondence.
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