N.S. UNI-GLOVES SDN. BHD.

FDA Device Registration & Listing · SEREMBAN Negeri Sembilan, MY · Registration 8040880

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
8040880
FEI Number
3430
Entity Name
N.S. UNI-GLOVES SDN. BHD.
City/State/Country
SEREMBAN Negeri Sembilan, MY
Establishment Address
LOT 3 & 4/4510 SENAWANG IND., ESTATE, SEREMBAN Negeri Sembilan 70450, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
N.S. UNI-GLOVES SDN. BHD. (Owner Number: 8040880)
Owner / Operator Contact Address
LOT 3 & 4/4510, Lorong Senawang 4/1, Senawang Industrial Estate, Seremban, MY-05 70450, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K062688
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
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2012-10-11
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2009-05-15
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2009-05-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2007-11-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2009-05-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2015-10-14
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2013-11-18
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2009-05-13

Official Correspondent

No official correspondent registered.

US Agent Details

Patrick Stanton Business: UG HEALTHCARE (USA), INC. Email: pat@ughealthcare.com Phone: (714) 4442248

Related Public Records

Same Entity

N.S. UNI-GLOVES SDN. BHD.
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
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21
K981039 Sri Johani Sdn. Bhd. POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) 1998-04-21
K101595 Better Care Plastic Technology Cp., Ltd. POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE 2010-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040880. Last updated year: 2026. Please use registration number 8040880 when referencing this establishment in official correspondence.
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