Hong Seng Gloves Sdn Bhd
Sungai Petani, MY
Hong Seng Gloves Sdn Bhd appears in FDA device records in Sungai Petani, 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 Hong Seng Gloves Sdn Bhd between 2021 and 2022. The busiest year on record is 2021, with 2. The most recent is 2022, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 2 |
| 2022 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221164 | Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | |
| K212801 | Powder free nitrile examination glove- black, non sterile | LZA | Substantially Equivalent | |
| K212802 | powder free nitrile examination glove - white, non-sterile | LZA | Substantially Equivalent | |
| K212804 | Powder free nitrile examination glove- blue, non-sterile | LZA | 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