HARPS Investment Asia Pte. Ltd.

Registration Details

Registration Name: HARPS Investment Asia Pte. Ltd.
Registration Number: 3010605427
FEI Number: 3010605427
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 9 Straits View, #08-10A, Marina One West Tower
City: Singapore Central Singapore
Country: SG

Regulatory Submissions

510(k) Number: K223752

Owner / Operator

Firm Name: HARPS Investment Asia Pte. Ltd.
Operator Number: 10045460
Address: 9 Straits View, #08-10A, Marina One West Tower
City: Singapore
State: SG-NOTA
Postal Code: 018937
Country: SG

US Agent

Business Name: Mansour Consulting LLC
Contact Name: Jay Mansour
Address: 845 Aronson Lake Court
City: Roswell
State: GA
ZIP: 30075
Country: US
Email: [email protected]
Phone: 678 9088180

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Fentanyl And Other Opioid Protection Glove	QDO	Class 1	General Hospital	No	2023-10-20
Polymer Patient Examination Glove	LZA	Class 1	General Hospital	No	2023-10-20
Medical Glove, Specialty	LZC	Class 1	General Hospital	No	2023-10-20
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	Class 1	General Hospital	No	2023-10-20
Surgeon'S Gloves	KGO	Class 1	General, Plastic Surgery	No	2015-04-09
Latex Patient Examination Glove	LYY	Class 1	General Hospital	No	2013-11-19

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 Select SemperForce Blue Nitrile (BLNF) Meadows Lyfemed Nitrile SPK-030VB 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 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 Syntegra PreCision Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves Kinberly-Clark * STERLING* Nitrile and STERLING* Nitrile-Xtra* Powder-Free Exam Gloves with Chemotheraphy Drug Use Claim Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves Essentials Nitrile Exam Gemini Nitrile Exam Tender Touch Nitrile PF 100 GlovePak Azurite Nitrile Exam Essentials Ultra Nitrile Exam Tender Touch Nitrile PF 200 Quality Choice Nitrile Exam Glove DealMed Nitrile Exam NBR PF VB 100pc Nitrident Touch 200 Nitrile Exam GlovePak Skye Nitrile Exam sempermed velvet (300) sempermed velvet XP (200) CARACAL velvet NBR PF VB 300pc DealMed Nitrile Exam NBR PF VB 300pc Nitrile SPK-035VB NBR PF VB 6pc SP Semperguard Xpert Sempermed Safe Touch 200 Nitrile Exam Patient Armor Blu IMCO powder free Nitrile Exam Gloves Nitrile SPK-030VB NBR PF VB 6pc StarMed PLUS StarMed ULTRA NITRILE Nitrile Exam NBR PF OB 100 sempermed velvet (100) sempermed velvet XP (250) DirectSafety Nitrile Light Exam PF Care One Nitrile Exam Semperguard Force+ Nitrident Comfort+ Latex patient examination glove Sempermed Derma Plus Powdered Latex Surgeon's Gloves Kimberly-Clark *Lavender* Nitrile Powder-Free Exam Gloves Powder Free Natural Rubber Latex Examination Gloves

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device