Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009056984

FEI Number

3009056984

Entity Name

QUALITY LATEX PRODUCTS (PVT) LTD

City/State/Country

hanwella Western, LK

Establishment Address

hanwella estate, pahathgama, hanwella Western NONE, LK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

QUALITY LATEX PRODUCTS (PVT) LTD (Owner Number: 10039153)

Owner / Operator Contact Address

3333 Finley Road, Downers Grove, IL 60515, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Resist a band Latex dam Resist a band

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2011-12-13
EIE	Dam, Rubber	Dental	Class 1	872.6300	2011-12-13
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2012-12-20

Official Correspondent

Melanie Leibowitz

US Agent Details

Melanie Leibowitz Email: melanie.leibowitz@performancehealth.com Phone: (331) 6889688

Related Public Records

Same Entity

QUALITY LATEX PRODUCTS (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
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009056984. Last updated year: 2026. Please use registration number 3009056984 when referencing this establishment in official correspondence.