Pt.Shamrock Manufacturing Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Pt.Shamrock Manufacturing Corp.” (first 2001, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 40 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 | 6 | 6 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Pt.Shamrock Manufacturing Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081040 | POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE | LYY | 2008-05-20 | 39 |
| K052709 | POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE | LYY | 2005-11-08 | 40 |
| K052382 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | 2005-09-15 | 16 |
| K030325 | POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM | LYY | 2003-03-28 | 56 |
| K030134 | LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE | LYY | 2003-03-25 | 70 |
| K030560 | POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE | LYY | 2003-03-21 | 28 |
| K011712 | LATEX EXAMINATION GLOVES- POWDER FREE, BLUE | LYY | 2001-07-17 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Pt.Shamrock Manufacturing Corp..
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.Shamrock Manufacturing Corp.?
FDA lists 7 510(k) clearances under the applicant name “Pt.Shamrock Manufacturing Corp.” (first 2001, latest 2008), 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.Shamrock Manufacturing Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pt.Shamrock Manufacturing Corp. is 40 days.
Which FDA product codes appear under Pt.Shamrock Manufacturing Corp.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 6); LZA (Polymer Patient Examination Glove, 1).
Next steps
- See all 7 Pt.Shamrock Manufacturing Corp. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Pt.Shamrock Manufacturing Corp.'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.