Pt. Universal Gloves
IndonesiaFDA applicant, unverified FDA FEI 3007471500
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Pt. Universal Gloves makes
Pt. Universal Gloves manufactures disposable examination gloves, including latex and nitrile varieties without powder, intended for single-use in medical and clinical settings. These gloves are designed for general examination and procedural tasks where barrier protection is required.
The company’s products are classified as Class I medical devices under FDA regulations and are supported by 510(k) clearance records. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3007471500
- Address
- JL. PERTAHANAN NO.17 PATUMBAK, DELI SERDANG, MEDAN Sumatera Utara
Frequently asked questions
How many devices does Pt. Universal Gloves have in the registry?
The registry currently lists 3 devices for Pt. Universal Gloves. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pt. Universal Gloves's devices?
Among its 3 most recently registered devices, Pt. Universal Gloves has devices listed in FDA 510(k) (3 devices).
What risk classes do Pt. Universal Gloves's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Pt. Universal Gloves's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pt. Universal Gloves in the registry?
The most recently registered devices listed for Pt. Universal Gloves include Disposable Latex Examination Gloves (Non-Sterile), Disposable Latex Powder Free Examination Gloves (Non-sterile) and Disposable Nitrile Powder Free Examination Gloves (Non-sterile).