Data / Medical devices / Malaysia / Asap International Sdn. Bhd.
Asap International Sdn. Bhd.: FDA-registered device maker in SHAH ALAM Selangor, Malaysia, 7 510(k) clearances
Asap International Sdn. Bhd. is registered with the FDA (registration 3014593437) in SHAH ALAM Selangor, Malaysia. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 20, 2017. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014593437
- Address
- No. 1, Jalan Sitar 33/6, Seksyen 33, SHAH ALAM Selangor, Malaysia, 40400
- Owner or operator
- ASAP INTERNATIONAL SDN. BHD. (10074712)
- Roles
- Exporter to the US
- First device listed
- May 29, 2020
- Registered through
- 2026
- Brand names listed
- ASAP, ASAP, Global Gloves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Exporter to the US | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| September 20, 2017 | K171541 | Powder Free Nitrile Examination Gloves (Orange) | LZA | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| September 8, 2017 | K171667 | Powder Free Nitrile Examination Glove | LZA | Substantially Equivalent | Professional Latex Sdn Bhd | accessdata.fda.gov |
| March 28, 2017 | K162405 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) | LZA | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| October 9, 2015 | K151528 | Powder Free Nitrile (Black) Examination Gloves | LZA | Substantially Equivalent | Gallant Quality Sdn. Bhd. | accessdata.fda.gov |
| December 3, 2008 | K081592 | POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES | LZA | Substantially Equivalent | Quality Gallant Sdn. Bhd. | accessdata.fda.gov |
| January 23, 2007 | K063524 | POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) | LZA | Substantially Equivalent | Hl Rubber Industries Sdn Bhd | accessdata.fda.gov |
| July 26, 2000 | K001619 | MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) | LZA | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
Updated September 20, 2017. 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.