Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014164734

FEI Number

3014164734

Entity Name

CAREGLOVE GLOBAL SDN BHD

City/State/Country

Seremban Negeri Sembilan, MY

Establishment Address

Lot 17479, Lorong Senawang 3/2,, Off Jln Senawang 3, Senawang Ind Estate, Seremban Negeri Sembilan 70450, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Careglove Global Sdn Bhd (Owner Number: 10051431)

Owner / Operator Contact Address

Lot 17479, Lorong Senawang 3/2,, Off Jln Senawang 3, Senawang Ind Estate, Seremban, MY-05 70450, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

6202 - Ultracare Latex Exam Glove - S - NS 6203 - Ultracare Latex Exam Glove - Unisize - NS 6204 - Ultracare Latex Exam Glove - L - NS powder-free nitrile examination gloves with aloe vera, green (tested for use with chemotherapy drugs) DR SMART BLUE NITRILE, NITRILECARE BLUE NITRILE EXAMINATION POWDER FREE GLOVES Nitrile Examination Gloves Powder Free (Green, Orange, Purple, White & Black) GLOVEPLUS PWD GP40100 GLOVEPLUS PWD GP44100 GLOVEPLUS PWD GP48100 GLOVEPLUS PWD GP46100 Rubbercare GLOVEPLUS PWD GP42100 SW N02840X Nitrile Examination Glove NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK) GLOVEPLUS PF GPPFT46100 GLOVEPLUS PF GPPFT48100 Guardian GLOVEPLUS PF GPPFT42100 GLOVEPLUS PF GPPFT40100 Rubbercare Ultra Care Plus LATEX EXAMINATION GLOVES POWDER FREE Chloroprene Examination Gloves Powder Free (Blue, Green) Powder Free Chloroprene Examination Glove Coloured (Blue, Green) Ambithix Rubbercare SW N70034X Exam Glove N18817X Biodegradable powder free nitrile examination glove, low dermatitis,potential claim

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2024-12-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-01-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-12-10
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-09-19
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2024-12-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-07-29
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-05-16
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-05-16
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-05-16
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-05-16
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2024-12-11
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2024-12-11
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2017-12-10
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-09-19
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2024-12-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-08-11

Official Correspondent

Kwee Shyan Lim

US Agent Details

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

Related Public Records

Same Entity

Careglove Global 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
K894452	Kerala Rubber & Reclaims, Ltd.	KRR GLOVE, PATIENT EXAMINATION GLOVES	1989-08-09
K891323	Li Wah-Hong Kong, Inc.	LI WAH LATEX EXAMINATION GLOVES	1989-08-31
K891418	C & K Mfg. & Sales Co.	LATEX EXAMINATION GLOVES, STYLE 510 LX	1989-06-22
K994255	Pt. Maja Agung Latexindo	LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE	2000-02-07
K892946	Yeou-Fwu Rubber Industrial Co., Ltd.	STERILE PATIENT EXAMINATION GLOVES	1989-08-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014164734. Last updated year: 2026. Please use registration number 3014164734 when referencing this establishment in official correspondence.