Data / Medical devices / Malaysia / Ansell Seremban Sdn. Bhd
Ansell Seremban Sdn. Bhd: FDA-registered device maker in Seremban Negeri Sembilan, Malaysia, 16 510(k) clearances
Ansell Seremban Sdn. Bhd is registered with the FDA (registration 3010436932) in Seremban Negeri Sembilan, Malaysia. It lists 6 device types. The FDA files 16 510(k) clearances under its listings, the newest dated October 20, 2023. 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
- 3010436932
- Address
- Lot 120 & 121, Jalan Senawang 3 Senawang Industrial Estate, Seremban Negeri Sembilan, Malaysia, 70450
- Owner or operator
- ANSELL HEALTHCARE PRODUCTS LLC (8020065)
- Roles
- Manufacturer
- First device listed
- January 13, 2020
- Registered through
- 2026
- Brand names listed
- Cobalt ® N19X, GAMMEX PI PLUS GLOVE-IN-GLOVE SYSTEM TESTED FOR USE WITH CHEMOTHERAPY DRUGS, LATEX EXAMINATION GLOVE, POWDER FREE WITH PROTEN CONTENT LABELING CLAIM (50 ug/g or less of total extractable Protein), MICROFLEX MIDKNIGHT MK-296, Micro-Touch Royal Blue, PI Hybrid Micro, POWDER FREE NITRILE EXAMINATION GLOVE BLACK AND DURAL COLOR WHITE-BLUE, POWDER FREE NITRILE EXAMINATION GLOVE WHITE (colored) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 20, 2023 | K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) | KGO | Substantially Equivalent | Ansell Healthcare | accessdata.fda.gov |
| May 26, 2023 | K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| October 6, 2021 | K211621 | Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) | KGO | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| August 20, 2021 | K203705 | Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) | LYY | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| August 20, 2021 | K201857 | Powder Free Nitrile Examination Glove Black and Dual Color White-Blue | LZA | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| August 3, 2021 | K210724 | ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | KGO | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| June 24, 2021 | K210656 | ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | KGO | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| May 27, 2021 | K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs | KGO | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| December 30, 2019 | K190241 | Sterile Latex Surgical Glove, Powder Free | KGO | Substantially Equivalent | Careglove Global Sdn. Bhd. | accessdata.fda.gov |
| November 20, 2018 | K181857 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| July 24, 2017 | K162858 | NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST | LZC | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| February 25, 2016 | K152593 | LATEX EXAMINATION GLOVE POWDER FREE | LYY | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| February 9, 2015 | K142858 | POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) | LZA | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| January 16, 2015 | K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). | LZA | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| May 21, 1999 | K990878 | BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| April 9, 1999 | K990543 | BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) | LYY | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Surgeon'S Gloves
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- 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 October 20, 2023. 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.