Pt. Smartglove Indonesia: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Pt. Smartglove Indonesia” (first 2003, latest 2014), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 78 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 | 1 | 227 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 9 | 9 |
| LYY | Latex Patient Examination Glove | 3 | 3 |
Review panels
- General Hospital (12)
Most recent Pt. Smartglove Indonesia 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133699 | POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES | LZA | 2014-07-18 | 227 |
| K101630 | POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE | LZA | 2010-09-07 | 89 |
| K101293 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) | LZA | 2010-07-01 | 52 |
| K092034 | POWDER FREE NITRILE EXAMINATION GLOVES, BLACK | LZA | 2009-10-19 | 105 |
| K041848 | POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR | LZA | 2004-08-20 | 43 |
| K040792 | POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) | LYY | 2004-08-12 | 136 |
| K040791 | POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) | LZA | 2004-06-03 | 66 |
| K030284 | POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE) | LZA | 2003-03-25 | 57 |
| K030406 | NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR | LZA | 2003-02-27 | 20 |
| K030112 | POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB | LYY | 2003-02-27 | 45 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pt. Smartglove Indonesia.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Pt. Smartglove Indonesia?
FDA lists 12 510(k) clearances under the applicant name “Pt. Smartglove Indonesia” (first 2003, latest 2014), 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 Pt. Smartglove Indonesia?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pt. Smartglove Indonesia is 78 days.
Which FDA product codes appear under Pt. Smartglove Indonesia?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 9); LYY (Latex Patient Examination Glove, 3).
Next steps
- See all 12 Pt. Smartglove Indonesia clearances with predicates and recalls
- Run predicate analysis for product code LZA, Pt. Smartglove Indonesia'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.