Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617453

FEI Number

3003158169

Entity Name

RIVERSTONE RESOURCES SDN. BHD.

City/State/Country

BUKIT BERUNTUNG, Selangor, MY

Establishment Address

LOT 55, NO. 13, JALAN JASMIN 2, Kawasan Perindustrian, Bukit Beruntung, BUKIT BERUNTUNG, Selangor 48300, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RIVERSTONE RESOURCES SDN. BHD. (Owner Number: 8040854)

Owner / Operator Contact Address

LOT 55, NO. 13 JALAN JASMIN 2, Kawasan Perindustrian, Bukit Beruntung, MY-10 48300, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133193

PMA Number

N/A

All Registered Proprietary Names

Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-03-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-03-29
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-01-04
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2024-01-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-01-04
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-01-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-05-28
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-06-08
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-06-08
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-12-19
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2019-12-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2010-08-06
LZB	Finger Cot	General Hospital	Class 1	880.6250	2015-04-16
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-05-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-05-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-05-28
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-08-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-08-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-01
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2014-07-05

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

RIVERSTONE RESOURCES SDN. BHD.

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

Similar Registrations

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3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3043739177	US Paper Mill LLC	Chillicothe, OH, US
3013681444	ANREL DISTRIBUTION LLC	Jackson, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617453. Last updated year: 2026. Please use registration number 9617453 when referencing this establishment in official correspondence.