LALAN RUBBERS (PVT) LTD.

FDA Device Registration & Listing · Malwana Gampaha, LK · Registration 3021595900

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
3021595900
FEI Number
3021595900
Entity Name
LALAN RUBBERS (PVT) LTD.
City/State/Country
Malwana Gampaha, LK
Establishment Address
No. 95/B, Zone A,, Export Processing Zone, Biyagama, Malwana Gampaha EPZ 11672, LK
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Lalan rubbers (Pvt) Ltd. (Owner Number: 10080597)
Owner / Operator Contact Address
No. 95/B, Zone A,, Export Processing Zone, Biyagama, Malwana, LK-11 EPZ 11672, LK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220697
PMA Number
N/A

All Registered Proprietary Names

N26088X N90975X NE 002

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 2025-07-01
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-01
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-07-01
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-12-13

Official Correspondent

Buddhima Herath

US Agent Details

Marissa Vilchez Email: m.vilchez@mdssar.com Phone: (312) 9751694

Related Public Records

Same Entity

Lalan 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
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 3021595900. Last updated year: 2026. Please use registration number 3021595900 when referencing this establishment in official correspondence.
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