Data / Medical devices / Singapore / HARPS Investment Asia Pte. Ltd.
HARPS Investment Asia Pte. Ltd.: FDA-registered device maker in Singapore Central Singapore, Singapore, 33 510(k) clearances
HARPS Investment Asia Pte. Ltd. is registered with the FDA (registration 3010605427) in Singapore Central Singapore, Singapore. It lists 6 device types. The FDA files 33 510(k) clearances under its listings, the newest dated August 19, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010605427
- Address
- 9 Straits View, #08-10A Marina One West Tower, Singapore Central Singapore, Singapore, 018937
- Owner or operator
- HARPS Investment Asia Pte. Ltd. (10045460)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- November 19, 2013
- Registered through
- 2027
- Brand names listed
- ADM Tex Latex, Black Colour Powder-Free Nitrile Rubber Examination Glove, Blackhawk Exam NBR PF VB, Blue Colour, Chlorinated Powder Free Nitrile Examination Gloves, CARACAL velvet NBR PF VB 300pc, Care One Nitrile Exam, CareMates 50CT PF, CareOne Nitrile NBR PF VB and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 19, 2025 | K250313 | Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid | KGO | Substantially Equivalent | Harps Europe Manufacturing GmbH | accessdata.fda.gov |
| July 24, 2023 | K223752 | Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl | LZA | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| July 20, 2023 | K230875 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims | LZA | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| May 23, 2023 | K230564 | Green Non Sterile Powder Free Nitrile Examination Gloves | LZA | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| January 27, 2023 | K223903 | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) | LZA | Substantially Equivalent | Semperit Investments Asia Pte , Ltd. | accessdata.fda.gov |
| December 22, 2021 | K211022 | Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. | LZA | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| March 31, 2020 | K191860 | Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential | KGO | Substantially Equivalent | Semperit Technische Produkte Gesellchaft M.B.H. | accessdata.fda.gov |
| October 4, 2019 | K183441 | Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Semperit Investments Asia Pte , Ltd. | accessdata.fda.gov |
| September 14, 2017 | K171378 | Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs | LZA | Substantially Equivalent | Semperit Investments Asia Pte , Ltd. | accessdata.fda.gov |
| May 2, 2017 | K160781 | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves | KGO | Substantially Equivalent | Semperit Investments Asia Pte , Ltd. | accessdata.fda.gov |
| January 22, 2015 | K143247 | Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) | LZA | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| June 29, 2012 | K120963 | POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Medtexx Manufacturing Sdn. Bhd. | accessdata.fda.gov |
| March 14, 2012 | K102189 | POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM | LZC | Substantially Equivalent | Latexx Manufacturing Sdn.Bhd. | accessdata.fda.gov |
| April 15, 2011 | K110921 | NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| July 14, 2008 | K081089 | KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM | LZC | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| July 9, 2008 | K081260 | KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES | LZA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| October 4, 2007 | K071740 | CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES | LZA | Substantially Equivalent | Medtexx Manufacturing Sdn. Bhd. | accessdata.fda.gov |
| May 10, 2007 | K070821 | POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE | LYY | Substantially Equivalent | Medtexx Manufacturing Sdn. Bhd. | accessdata.fda.gov |
| March 15, 2007 | K070072 | NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Medtexx Manufacturing Sdn. Bhd. | accessdata.fda.gov |
| August 3, 2005 | K051378 | POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | Medline | accessdata.fda.gov |
| March 15, 2004 | K034052 | BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES | LZA | Substantially Equivalent | Latexx Manufacturing Sdn.Bhd. | accessdata.fda.gov |
| November 13, 2003 | K032444 | NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY | LZC | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| October 11, 2002 | K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| August 15, 2002 | K022548 | MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES | LZA | Substantially Equivalent | Latexx Manufacturing Sdn.Bhd. | accessdata.fda.gov |
| March 4, 2002 | K014087 | LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | Latexx Manufacturing Sdn.Bhd. | accessdata.fda.gov |
| January 16, 2002 | K013560 | SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 | KGO | Substantially Equivalent | Semperit Technische Produkte Gesellshaft | accessdata.fda.gov |
| November 16, 2001 | K012819 | SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 | KGO | Substantially Equivalent | Semperit Technische Produkte Gesellshaft | accessdata.fda.gov |
| August 22, 2001 | K011749 | LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS | LYY | Substantially Equivalent | Sempermed USA, Inc. | accessdata.fda.gov |
| August 30, 1999 | K992162 | SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM | LZC | Substantially Equivalent | Safeskin Corp. | accessdata.fda.gov |
| October 29, 1998 | K981096 | SEMPERMED SURGEONS' GLOVES - SUPREME | KGO | Substantially Equivalent | Semperit Technische Produkte Gesellshaft | accessdata.fda.gov |
| June 11, 1998 | K981767 | QTEXX POWDERFREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Latexx Partners Bhd. | accessdata.fda.gov |
| June 1, 1998 | K981159 | PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Latexx Partners Bhd. | accessdata.fda.gov |
| April 26, 1989 | K891223 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent | Sin Super Holdings Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Surgeon'S Gloves
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
Updated August 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.