Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012551999

FEI Number

3012551999

Entity Name

ST.MARYS RUBBERS PVT LTD

City/State/Country

Kottayam Kerala, IN

Establishment Address

XVII / 401 A, THOTTAMKAVALA, KOOVAPPALLY P O, KANJIRAPPALLY, Kottayam Kerala 686518, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ST.MARYS RUBBERS PVT LTD (Owner Number: 10050794)

Owner / Operator Contact Address

XVII / 401 A, THOTTAMKAVALA, KOOVAPPALLY P O, KANJIRAPPALLY, KOTTAYAM, IN-KL 686518, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151114

PMA Number

N/A

All Registered Proprietary Names

Safe Touch SUPERFIT Medismart Medismart + Mediagni PF Medismart Premium Plus ICP Meds One glove plus Oasis Amerisourcebergen Mediten plus Med pride Medix Mediten PLus

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	2015-12-28

Official Correspondent

No official correspondent registered.

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

ST.MARYS RUBBERS PVT LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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

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9610406	ANSELL (THAILAND) LTD.	THAILAND Krung Thep Maha Nakhon, TH
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
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 3012551999. Last updated year: 2026. Please use registration number 3012551999 when referencing this establishment in official correspondence.