Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010605427

FEI Number

3010605427

Entity Name

HARPS Investment Asia Pte. Ltd.

City/State/Country

Singapore Central Singapore, SG

Establishment Address

9 Straits View, #08-10A, Marina One West Tower, Singapore Central Singapore 018937, SG

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

HARPS Investment Asia Pte. Ltd. (Owner Number: 10045460)

Owner / Operator Contact Address

9 Straits View, #08-10A, Marina One West Tower, Singapore, SG-NOTA 018937, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191860

PMA Number

N/A

All Registered Proprietary Names

Emerald 3X Black Nitrile Semperguard force black SemperForce BLACK DealMed Black NBR PF BK 100pcs Emerald 4X Black Nitrile semperguard sapphire XP black Sempermed Supreme Powder Free Latex Surgeon's Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Blue Colour, Chlorinated Powder Free Nitrile Examination Gloves DealMed Nitrile Exam (200 count) DealMed Nitrile Exam (100 count) StarMed Plus DealMed Latex Exam DealMed Nitrile Exam (300 count) StarMed StarMed Plus Nitrile VB StarMed Select NBR VB SP Nitrile Exam NBR PF OB Paladin Nitrile Exam NBR PF VB Direct Safety Light NBR PF VB PATIENT ARMOR BLU NBR PF VB DealMed Nitrile NBR PF VB Nitrile Exam 200 NBR PF VB GlovePak Azurite PF NBR VB Touch 200 Nitrile Glove Pak Skye Nitrile NBR PF VB Nitrile Exam PF 3.5 StarMed Select NBR VB Nitrile Exam PF 3.5 NBR PF VB CareOne Nitrile NBR PF VB Blackhawk Exam NBR PF VB Nitrident Touch NBR PF VB Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotheraphy Drugs) Qtexx Powder-Free Latex Examination Gloves with 50 Micrograms or Less of Total Water Extractable Protein Per Gram Black Colour Powder-Free Nitrile Rubber Examination Glove StarMed Black Nitrile Emerald 3X NBR PF BK Emerald 4X NBR PF BK StarMed Ultra Nitrile NBR PF VB 250pc Tender Touch NBR PF VB 100pc M Quality Choice Nitrile Exam NBR PF VB Nitrile SPK-030VB NBR PF VB 6pc SP (Sample Glove) Nitrile SPK-035VB NBR PF VB 6pc SP (Sample Gloves) semperguard force blue Nitrile Exam 200 NBR PF VB 200pc (IMCO) StarMed Select NBR PF VB 100pc Nitrile Exam NBR PF OB (IMCO) Tender Touch NBR PF VB 200 pc SemperForce Blue Nitrile NBR PF OB 100pc StarMed Plus NBR PF VB 300pc semperguard Xpert SM US iconiX NBR PF DB 6pc SM US iconiX NBR PF DB 100pc Powdered Natural Rubber Latex Examination Gloves (Protein Label Claim) Starmed Ultra Fresen Starmed Ultra Nitrile Tender Touch NBR PF VB Nitrile SPK-035VB NBR PF VB StarMed Plus StarMed Select SemperForce Blue Nitrile (BLNF) Meadows Lyfemed Nitrile SPK-030VB NBR PF VB Nitrile Exam 200 NBR PF VB DealMed Nitrile Gemini Nitrile Exam NBR PF VB Tender Touch NBR Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Gloves Winco 50ct PF CareMates 50CT PF Latex EXAM NR PF SemperCare Latex SPK NR PF Dealmed Latex NR PF GlovePak Azurite PF NBR VB Health Shield 50ct PF Pro-Medix Exam NR PF Guardian NR PF ADM Tex Latex GMX Textured PF Latex Essential Cares Latex NR PF Rely-a-Grip LP NR PF SemperCare Latex PF Grainger Condor Latex NR PF Nitrile Cornflower Blue Powder-Free Exam Tested for Use with Chemotherapy Drugs (Non-Sterile) Safeskin Purple Powder-Free Nitrile Examination Gloves For Use With Chemotherapeutic Drugs Labeling Claim. Patient examination glove, specialty Nitrile Powder-Free Examination Gloves Allegiance Healthcare Corp. Nitrile Powder-Free Examination Gloves Powder-Free Blue Nitrile Examination Gloves with Tested For Use with Chemotherapy Drugs labeling Claim Latexx Manufacturing Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Gloves. Medtexx Powder Free Latex SemperSure Green Nitrile Examination Gloves (SUNG201-SUNG205) Sempersure Green NBR PF GR sempermed green (200) semperguard sapphire XP white Natural Extension Ultra2 CO 300pc Raven White Exam NBR PF WH 100pc Nitrile Powder-Free Examination Gloves with Lotion Coating and Use for Chemotherapy Patient Examination Gloves (Latex) Proflex* Powder Free Nitrile Examination Gloves Syntegra Green SEMPERMED SURGEONS' GLOVES - SUPREME Sempermed Syntegra UV

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-10-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-10-20
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-10-20
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-10-20
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2015-04-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-11-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-11-19
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-11-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-11-19
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-02-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-02-27
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-02-27
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-02-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-06-03
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-06-03
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2025-06-03
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-06-03
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-11-19
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-11-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-11-19
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-11-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-11-19
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2013-11-19
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-01-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-11-19
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-11-19
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2019-10-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-10-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-09-24
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-02-01
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2013-11-19
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-11-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-11-19
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-12-04
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2025-12-04
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-11-03
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2020-06-10

Official Correspondent

No official correspondent registered.

US Agent Details

Jay Mansour Business: Mansour Consulting LLC Email: jay@mansourconsulting.com Phone: (678) 9088180

Related Public Records

Same Entity

HARPS Investment Asia Pte. 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 3010605427. Last updated year: 2026. Please use registration number 3010605427 when referencing this establishment in official correspondence.