Platinum Glove Industries Sdn. Bhd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Platinum Glove Industries Sdn. Bhd.” (first 2005, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time under this name: 77 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 362 |
| 2020 | 0 | — |
| 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 Platinum Glove Industries Sdn. Bhd. took a median 362 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 | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Platinum Glove Industries Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182089 | Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs | LZA | 2019-07-30 | 362 |
| K091965 | POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED | LZA | 2009-11-24 | 146 |
| K080165 | SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY) | LZA | 2008-05-14 | 112 |
| K051372 | POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR) | LZA | 2005-07-07 | 42 |
| K051317 | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR | LZA | 2005-06-20 | 31 |
| K051318 | POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR) | LZA | 2005-06-17 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Platinum Glove Industries 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.
- Platinum Services, Inc. (2 510(k)s)
- Platinum Team Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Platinum Glove Industries Sdn. Bhd.?
FDA lists 6 510(k) clearances under the applicant name “Platinum Glove Industries Sdn. Bhd.” (first 2005, latest 2019), across 1 product code 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 Platinum Glove Industries Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Platinum Glove Industries Sdn. Bhd. is 77 days.
Which FDA product codes appear under Platinum Glove Industries Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 6).
Next steps
- See all 6 Platinum Glove Industries Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Platinum Glove Industries 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.