Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613494

FEI Number

3012355534

Entity Name

MIDAS SAFETY LANKA (PRIVATE) LIMITED

City/State/Country

AVISSAWELLA Western, LK

Establishment Address

PRIME POLYMERS DIVISION, D 17, SEETHAWAKA EXPORT PROCESSING ZONE, AVISSAWELLA Western 10700, LK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MIDAS SAFETY LANKA (PVT) LTD. (Owner Number: 9038698)

Owner / Operator Contact Address

No. 78, BIYAGAMA EXPORT PROCESSING ZONE, WALGAMA,, MALWANA,, LK-1 11672, LK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122464

PMA Number

N/A

All Registered Proprietary Names

Midas Touch¿ Midas Touch Midas Touch SHELBY GROUP INTL., INC. Midas Touch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-07
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-12
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-05-27
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-01-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2015-07-16
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-05-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

MIDAS SAFETY LANKA (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
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21
K101595	Better Care Plastic Technology Cp., Ltd.	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE	2010-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613494. Last updated year: 2026. Please use registration number 9613494 when referencing this establishment in official correspondence.