ANSELL LANKA (PVT.), LTD.

FDA Device Registration & Listing · BIYAGAMA Gampaha, LK · Registration 8041180

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
8041180
FEI Number
3002806389
Entity Name
ANSELL LANKA (PVT.), LTD.
City/State/Country
BIYAGAMA Gampaha, LK
Establishment Address
BIYAGAMA EXPORT PROCESSING, ZONE,, BIYAGAMA Gampaha --, LK
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
K993857
PMA Number
N/A

All Registered Proprietary Names

GAMMEX PI PLUS GLOVE-IN-GLOVE SYSTEM TESTED FOR USE WITH CHEMOTHERAPY DRUGS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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 2019-05-29
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 2007-12-17
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 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
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-02-05
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
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 2007-12-05

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
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
9610406 ANSELL (THAILAND) LTD. THAILAND Krung Thep Maha Nakhon, TH
3012551999 ST.MARYS RUBBERS PVT LTD Kottayam Kerala, IN
3025413681 GUILIN HUADA BIOTECHNOLOGY CO., LTD. Guilin City Guangxi, CN
8041005 WRP ASIA PACIFIC SDN. BHD. SALAK TINGGI, SEPANG Selangor, MY
3004122598 PRODUCTOS MEDLINE S.A. DE C.V. NUEVO LAREDO Tamaulipas, MX
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8041180. Last updated year: 2026. Please use registration number 8041180 when referencing this establishment in official correspondence.
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