Hartalega Sdn Bhd: FDA filings under this applicant name
FDA lists 61 510(k) clearances under the applicant name “Hartalega Sdn Bhd” (first 1989, latest 2020), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 108 days. Since 2017 the median was 108 days, against 118 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 143 |
| 2013 | 3 | 133 |
| 2014 | 4 | 156 |
| 2015 | 2 | 92 |
| 2016 | 3 | 115 |
| 2017 | 6 | 102 |
| 2018 | 5 | 221 |
| 2019 | 0 | — |
| 2020 | 3 | 59 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hartalega Sdn Bhd took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 33 | 33 |
| LYY | Latex Patient Examination Glove | 19 | 19 |
| KGO | Surgeon'S Gloves | 8 | 8 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (61)
Most recent Hartalega Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201748 | Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs | KGO | 2020-10-02 | 98 |
| K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | 2020-08-05 | 58 |
| K200897 | Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) | KGO | 2020-06-01 | 59 |
| K180645 | Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) | LZA | 2018-11-16 | 249 |
| K180786 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff | LZA | 2018-11-02 | 221 |
| K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue) | LZA | 2018-08-17 | 277 |
| K180644 | Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green | LZA | 2018-08-10 | 151 |
| K180505 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) | LZA | 2018-06-14 | 108 |
| K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) | LZA | 2017-12-12 | 74 |
| K171874 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) | LZA | 2017-10-12 | 111 |
51 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hartalega Sdn Bhd.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hartalega NGC Sdn. Bhd. (31 510(k)s)
- Hartalega Sdb. Bhd. (4 510(k)s)
- Hartalega Snd. Bhd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hartalega Sdn Bhd?
FDA lists 61 510(k) clearances under the applicant name “Hartalega Sdn Bhd” (first 1989, latest 2020), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hartalega Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hartalega Sdn Bhd is 108 days. Since 2017: 108 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hartalega Sdn Bhd?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 33); LYY (Latex Patient Examination Glove, 19); KGO (Surgeon'S Gloves, 8).
Next steps
- See all 61 Hartalega Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LZA, Hartalega Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.