Pt. Sintong Unigolden Glove
IndonesiaFDA applicant, unverified FDA FEI 3025303965
- Devices
- 7
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Pt. Sintong Unigolden Glove makes
Pt. Sintong Unigolden Glove manufactures non-powdered, non-antimicrobial nitrile examination and treatment gloves. Their product range includes standard nitrile examination gloves as well as specialized variants tested for use with chemotherapy drugs.
These devices are classified as Class I medical products and are based in the United States. The company maintains listings for its portfolio within the FDA 510(k) and FDA UDI regulatory databases.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3025303965
- DUNS number
- 565034612
- Address
- JL. LINTAS SUMATERA, HESSA PERLOMPONGAN, KISARAN Sumatera Utara
- [email protected]
- Phone
- +6281253206449
Frequently asked questions
How many devices does Pt. Sintong Unigolden Glove have in the registry?
The registry currently lists 7 devices for Pt. Sintong Unigolden Glove. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pt. Sintong Unigolden Glove's devices?
Among its 7 most recently registered devices, Pt. Sintong Unigolden Glove has devices listed in FDA 510(k) (1 device) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Pt. Sintong Unigolden Glove's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Pt. Sintong Unigolden Glove's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pt. Sintong Unigolden Glove in the registry?
The most recently registered devices listed for Pt. Sintong Unigolden Glove include Nitrile Examination Gloves Powder Free Small, Nitrile Examination Gloves Powder Free X - Large, Nitrile Examination Gloves Powder Free Medium and Nitrile Examination Gloves Powder Free Large.