Central Medicare Sdn Bhd: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Central Medicare Sdn Bhd” (first 2010, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 171 days. Since 2017 the median was 171 days, against 112 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 | 184 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 71 |
| 2016 | 0 | — |
| 2017 | 2 | 86 |
| 2018 | 1 | 69 |
| 2019 | 1 | 233 |
| 2020 | 0 | — |
| 2021 | 2 | 238 |
| 2022 | 1 | 171 |
| 2023 | 4 | 158 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Central Medicare Sdn Bhd took a median 171 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 11 | 11 |
| LZC | Medical Glove, Specialty | 4 | 4 |
Review panels
- General Hospital (15)
Most recent Central Medicare Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230681 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl | LZA | 2023-10-02 | 203 |
| 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 | 2023-07-24 | 221 |
| K230875 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims | LZA | 2023-07-20 | 112 |
| K230564 | Green Non Sterile Powder Free Nitrile Examination Gloves | LZA | 2023-05-23 | 83 |
| K213437 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims | LZA | 2022-04-11 | 171 |
| K211022 | Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. | LZA | 2021-12-22 | 261 |
| K203036 | Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) | LZA | 2021-05-07 | 214 |
| K183149 | Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim | LZC | 2019-07-04 | 233 |
| K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | LZC | 2018-03-05 | 69 |
| K172642 | Orange Non Sterile Powder Free Nitrile Examination Gloves | LZC | 2017-11-28 | 88 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Central Medicare 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.
Device clinical trials
An industry sponsor named Central Medicare Sdn Bhd is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03886987: Skin Sensitization Test (Modified Draize-95 Test) (Completed, started 2018-04-02)
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.
- Central Media (14 510(k)s)
- Central Solutions, Inc. (7 510(k)s)
- Central Biological Co. (5 510(k)s)
- Central Georgia Ancillary Health Systems (3 510(k)s)
- Central Labs. Assoc. MD Pathologists (3 510(k)s)
- Central Plastic, Inc. (2 510(k)s)
- Central Chemical Co., Ltd. (1 510(k)s)
- Central Equipment Sales, Inc. (1 510(k)s)
- Central Illinois Hearing Aid Centers, Inc. (1 510(k)s)
- Central Pharmaceuticals, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Central Medicare Sdn Bhd?
FDA lists 15 510(k) clearances under the applicant name “Central Medicare Sdn Bhd” (first 2010, latest 2023), across 2 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 Central Medicare Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Central Medicare Sdn Bhd is 171 days. Since 2017: 171 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Central Medicare Sdn Bhd?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 11); LZC (Medical Glove, Specialty, 4).
Next steps
- See all 15 Central Medicare Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LZA, Central Medicare 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.