ANSELL HEALTHCARE PRODUCTS LLC

FDA Device Registration & Listing · Reno, NV, US · Registration 3011209798

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
3011209798
FEI Number
3011209798
Entity Name
ANSELL HEALTHCARE PRODUCTS LLC
City/State/Country
Reno, NV, US
Establishment Address
2301 Robb Drive, Reno, NV 89523, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,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
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

POWDER FREE NITRILE EXAMINATION GLOVE BLACK AND DURAL COLOR WHITE-BLUE MICROFLEX MIDKNIGHT MK-296 GAMMEX PI PLUS GLOVE-IN-GLOVE SYSTEM TESTED FOR USE WITH CHEMOTHERAPY DRUGS KIT TURNOVER STAT-PAC STAT-BLOC™ Premium, Antimicrobial, Wide Table Sheet (90") w/ Elastic Edging at Head and Foot PI Hybrid Micro

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 2022-03-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-03-07
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-05-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-01-06
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-03
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2007-12-05
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2019-09-16
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-03-10
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-03-10
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2007-12-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-08-20
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-08-20
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-01-07
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-01-07
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2007-12-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-03-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-03-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2007-11-21
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2023-05-30
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-05-30
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-05-30
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-03
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2007-12-05
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 2020-03-05
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2007-11-29
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2009-10-26
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2009-10-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-08-23
IWP Radiographic Protective Glove Radiology Class 1 892.6500 2020-01-06
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-01-07
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-06-17
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2021-06-17
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2019-09-16
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-10-27
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2021-10-27
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2013-01-09
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2022-01-07
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-03-14
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2019-09-16
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-01-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-03
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-01-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-03
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
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-06-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-11-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2021-02-16
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-11-05
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-11-05
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-02-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-03-17
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2019-09-18
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-01-30
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2007-11-28
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2022-01-07
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-04-17
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2013-04-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-12-01
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2021-12-15
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2017-02-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2010-05-26
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-03-17
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-03-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-03-17
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2011-08-26
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-05-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
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 2017-03-07
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2008-06-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-06-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-07-27
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2017-01-25
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-02-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2015-04-29
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2015-04-29
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-03
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-01-03
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-01-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-05-04
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2021-12-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-07-31
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2007-12-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-08-03
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2020-08-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-08-03
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2019-09-18
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2007-12-05
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-12-17
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2021-12-17
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2015-04-29
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2019-09-04

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
3009964047 ANSELL HEALTHCARE PRODUCTS LLC Iselin, NJ, US
3003199637 Ansell Canada Inc. Cowansville Quebec, CA
3004125670 Ansell Sandel Medical Solutions LLC CHATSWORTH, CA, US

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 3011209798. Last updated year: 2026. Please use registration number 3011209798 when referencing this establishment in official correspondence.
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