Platinum Glove Industries Sdn. Bhd.
Kuala Lumpur, MY
Platinum Glove Industries Sdn. Bhd. appears in FDA device records in Kuala Lumpur, MY. FDA records list 6 510(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
- 6
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 6 510(k) clearances for Platinum Glove Industries Sdn. Bhd. between 2005 and 2019. The busiest year on record is 2005, with 3. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 3 |
| 2008 | 1 |
| 2009 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K182089 | Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | |
| K091965 | POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED | LZA | Substantially Equivalent | |
| K080165 | SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY) | LZA | Substantially Equivalent | |
| K051372 | POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR) | LZA | Substantially Equivalent | |
| K051317 | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR | LZA | Substantially Equivalent | |
| K051318 | POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR) | 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