ANSELL HEALTHCARE PRODUCTS LLC

FDA Device Registration & Listing · Iselin, NJ, US · Registration 3009964047

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
3009964047
FEI Number
3009964047
Entity Name
ANSELL HEALTHCARE PRODUCTS LLC
City/State/Country
Iselin, NJ, US
Establishment Address
111 Wood Ave S Suite 210, Iselin, NJ 08830, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ANSELL HEALTHCARE PRODUCTS LLC (Owner Number: 8020065)
Owner / Operator Contact Address
2301 Robb Drive, Reno, NV 89523, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K151528
PMA Number
N/A

All Registered Proprietary Names

LATEX EXAMINATION GLOVE, POWDER FREE WITH PROTEN CONTENT LABELING CLAIM (50 ug/g or less of total extractable Protein)

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 2023-05-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-08-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-01-03

Official Correspondent

Don Cronk

US Agent Details

No US Agent registered (Local establishment).

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
9610406 ANSELL (THAILAND) LTD. THAILAND Krung Thep Maha Nakhon, TH
3010459874 Ansell Perry de Mexico S.A. de C.V. Cd. Juarez Chihuahua, MX
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
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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1000266564 SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED. Hat Yai Songkhla, TH
8040653 ARISTA LATINDO INDUSTRIAL, LTD. P.T. JAKARTA BARAT, ID
3002661124 ULINE, INC. Pleasant Prairie, WI, US
3019769825 HARTALEGA NGC SDN. BHD. (LOT 39496) Sepang Selangor, MY
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009964047. Last updated year: 2026. Please use registration number 3009964047 when referencing this establishment in official correspondence.
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