Hartalega Sdb. Bhd.
Bandar Sri Damansara, MY
Hartalega Sdb. Bhd. appears in FDA device records in Bandar Sri Damansara, MY. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 4
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 4 510(k) clearances for Hartalega Sdb. Bhd. between 2014 and 2017. The busiest year on record is 2014, with 2. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162924 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) | LZA | Substantially Equivalent | |
| K160928 | Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) | KGO | Substantially Equivalent | |
| K142805 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) | LZA | Substantially Equivalent | |
| K142270 | LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE | LYY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain