Data / Medical devices / Indonesia / Pt.shamrock Manufacturing Corp.
Pt.shamrock Manufacturing Corp.: FDA-registered device maker in MEDAN Sumatera Utara, Indonesia, 9 510(k) clearances
Pt.shamrock Manufacturing Corp. is registered with the FDA (registration 3003958472) in MEDAN Sumatera Utara, Indonesia. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 23, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003958472
- Address
- Jalan Pemuda No. 11, MEDAN Sumatera Utara, Indonesia, 20151
- Owner or operator
- PT.SHAMROCK MANUFACTURING CORPORA (9050434)
- Roles
- Manufacturer
- First device listed
- December 3, 2007
- Registered through
- 2027
- Brand names listed
- Shamrock
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 23, 2022 | K211810 | Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) | LZA | Substantially Equivalent | Pt. Shamrock Manufacturing Corpora | accessdata.fda.gov |
| May 20, 2008 | K081040 | POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE | LYY | Substantially Equivalent | Pt.Shamrock Manufacturing Corp. | accessdata.fda.gov |
| November 8, 2005 | K052709 | POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE | LYY | Substantially Equivalent | Pt.Shamrock Manufacturing Corp. | accessdata.fda.gov |
| September 15, 2005 | K052382 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Pt.Shamrock Manufacturing Corp. | accessdata.fda.gov |
| March 28, 2003 | K030386 | POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE | LZA | Substantially Equivalent | Shamrock Manufacturing Company | accessdata.fda.gov |
| March 28, 2003 | K030325 | POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM | LYY | Substantially Equivalent | Pt.Shamrock Manufacturing Corp. | accessdata.fda.gov |
| March 25, 2003 | K030134 | LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE | LYY | Substantially Equivalent | Pt.Shamrock Manufacturing Corp. | accessdata.fda.gov |
| March 21, 2003 | K030560 | POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE | LYY | Substantially Equivalent | Pt.Shamrock Manufacturing Corp. | accessdata.fda.gov |
| July 17, 2001 | K011712 | LATEX EXAMINATION GLOVES- POWDER FREE, BLUE | LYY | Substantially Equivalent | Pt.Shamrock Manufacturing Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Latex Patient Examination Glove
Updated May 23, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.