Pt.Shamrock Manufacturing Corp.
United StatesFDA applicant, unverified FDA
- Devices
- 7
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Pt.Shamrock Manufacturing Corp. makes
Pt.Shamrock Manufacturing Corp. produces powder-free and powdered latex examination gloves, including variants with neoprene lining and flavored interiors such as grape and bubblegum. Their portfolio also includes powder-free nitrile examination gloves in blue, available in multiple sizes.
All listed devices fall under FDA Class I regulation and are recorded in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Powderfree Latex Examination Gloves With Grape Ref K030560
Regimes: 510(k) Registry: 510(k)Latex Examination Gloves- Powder Free, Blue Ref K011712
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Powder Free Nitrile Examination Gloves, Blue Ref K052382
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Latex Examination Gloves Powder Free With Neoprene Lined, Sizes Xsmall, Small, Medium, Large, Xlarge Ref K030134
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Pt.shamrock Manufacturing Corp. MEDAN Sumatera Utara · ID FEI 3003958472
Frequently asked questions
How many devices does Pt.Shamrock Manufacturing Corp. have in the registry?
The registry currently lists 7 devices for Pt.Shamrock Manufacturing Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pt.Shamrock Manufacturing Corp.'s devices?
Among its 7 most recently registered devices, Pt.Shamrock Manufacturing Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Pt.Shamrock Manufacturing Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Pt.Shamrock Manufacturing Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pt.Shamrock Manufacturing Corp. in the registry?
The most recently registered devices listed for Pt.Shamrock Manufacturing Corp. include POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE, LATEX EXAMINATION GLOVES- POWDER FREE, BLUE, POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM and POWDER FREE NITRILE EXAMINATION GLOVES, BLUE.
Which FDA establishments are linked to Pt.Shamrock Manufacturing Corp.?
1 FDA establishment is linked to Pt.Shamrock Manufacturing Corp. in the registry; they are listed on the company page.