ANSELL (THAILAND) LTD.

FDA Device Registration & Listing · THAILAND Krung Thep Maha Nakhon, TH · Registration 9610406

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
9610406
FEI Number
3002806370
Entity Name
ANSELL (THAILAND) LTD.
City/State/Country
THAILAND Krung Thep Maha Nakhon, TH
Establishment Address
74 SOI CHALONGKRUNG 31, KHWANG LAMPLATIEW, KHET LAT KRABANG, THAILAND Krung Thep Maha Nakhon 10520, TH
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ANSELL HEALTHCARE PRODUCTS LLC (Owner Number: 8020065)
Owner / Operator Contact Address
2301 Robb Drive, Reno, NV 89523, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231902
PMA Number
N/A

All Registered Proprietary Names

PI Hybrid Micro

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 2021-06-14
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-06-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-06-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2023-12-19
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

Don Cronk Email: don.cronk@ansell.com Phone: (775) 4707106

Related Public Records

Same Entity

ANSELL HEALTHCARE PRODUCTS LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010459874 Ansell Perry de Mexico S.A. de C.V. Cd. Juarez Chihuahua, MX
3009964047 ANSELL HEALTHCARE PRODUCTS LLC Iselin, NJ, US
3003199637 Ansell Canada Inc. Cowansville Quebec, CA
3004125670 Ansell Sandel Medical Solutions LLC CHATSWORTH, CA, US
8043736 ANSELL N.P. SDN. BHD. MELAKA, MY

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 9610406. Last updated year: 2026. Please use registration number 9610406 when referencing this establishment in official correspondence.
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