Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024706752

FEI Number

3024706752

Entity Name

Ansell Sterile Solutions Pvt. Ltd

City/State/Country

Erode Tamil Nadu, IN

Establishment Address

Plot No-KK 10, KK-11, SIPCOT Industrial Park, Phase-II, 3rd Cross Road, Perundurai, Erode Tamil Nadu 638052, IN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ANSELL HEALTHCARE PRODUCTS LLC (Owner Number: 8020065)

Owner / Operator Contact Address

2301 Robb Drive, Reno, NV 89523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
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
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2015-04-29
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-11-29
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	2007-12-05
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2015-11-10
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-11-28
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	2021-10-27
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2021-10-27
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2019-09-13
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
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-12-05
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
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	2016-11-03
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2016-11-03
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
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-12-17

Official Correspondent

Don Cronk

US Agent Details

Don Cronk Business: ANSELL HEALTHCARE PRODUCTS LLC 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
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
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02

Similar Registrations

Registration Number	Establishment Name	Location
3030671502	GUANGDONG VYIMED CO., LTD.	Qingyuan Guangdong, CN
9610406	ANSELL (THAILAND) LTD.	THAILAND Krung Thep Maha Nakhon, TH
3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3043739177	US Paper Mill LLC	Chillicothe, OH, US
3013681444	ANREL DISTRIBUTION LLC	Jackson, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024706752. Last updated year: 2026. Please use registration number 3024706752 when referencing this establishment in official correspondence.