Pt. Wrp Buana Multicorpora: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Pt. Wrp Buana Multicorpora” (first 2000, latest 2003), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 54 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 | 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 4 | 4 |
| LZA | Polymer Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (6)
Most recent Pt. Wrp Buana Multicorpora 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032011 | GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE | LZA | 2003-08-19 | 50 |
| K032010 | GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE | LZA | 2003-08-19 | 50 |
| K032007 | GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR | LYY | 2003-07-28 | 28 |
| K030273 | GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE | LYY | 2003-03-26 | 58 |
| K022343 | GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS) | LYY | 2002-09-16 | 59 |
| K994426 | GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING) | LYY | 2000-05-23 | 145 |
Recalls
openFDA lists no recalls under a recalling firm named Pt. Wrp Buana Multicorpora.
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. Wrp Buana Multicorpora?
FDA lists 6 510(k) clearances under the applicant name “Pt. Wrp Buana Multicorpora” (first 2000, latest 2003), 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. Wrp Buana Multicorpora?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pt. Wrp Buana Multicorpora is 54 days.
Which FDA product codes appear under Pt. Wrp Buana Multicorpora?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 4); LZA (Polymer Patient Examination Glove, 2).
Next steps
- See all 6 Pt. Wrp Buana Multicorpora clearances with predicates and recalls
- Run predicate analysis for product code LYY, Pt. Wrp Buana Multicorpora'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.