Top Glove Medical (Thailand) Co., Ltd.
Active in EUDAMEDThailandfrom SRN EUDAMED FDA SRN TH-MF-000018387 FEI 3003851058
- Devices
- 8
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Top Glove Medical (Thailand) Co., Ltd. makes
Top Glove Medical (Thailand) Co., Ltd. manufactures examination gloves, including powdered latex gloves, polymer-coated powder-free latex gloves, and nitrile examination gloves. The nitrile gloves are tested for use with 32 chemotherapy drugs and fentanyl permeation resistance. These products are designed for medical and healthcare settings to provide barrier protection during procedures.
The company’s portfolio consists of Class I medical devices, which are generally considered low-risk. These gloves are listed under the FDA’s 510(k) pathway, indicating they meet regulatory requirements for marketing in the United States. The manufacturer is based in the US.
Catalogue
Safety + Comfort Ref ABO-971982024
Regimes: CE MDR Registry: EUDAMEDSafety + Comfort Ref ABO-971982023
Regimes: CE MDR Registry: EUDAMEDSafety + Comfort Ref ABO-971982026
Regimes: CE MDR Registry: EUDAMEDSafety + Comfort Ref ABO-971982022
Regimes: CE MDR Registry: EUDAMEDSafety + Comfort Ref ABO-971982025
Regimes: CE MDR Registry: EUDAMED- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- TH-MF-000018387
- FDA FEI number
- 3003851058
- EUDAMED status
- Active
- EUDAMED registered name
- TOP GLOVE MEDICAL (THAILAND) CO., LTD.
- Registered address
- 188, 189, 190, MOO 5, KARNCHANAWANICH ROAD, 90320, SONGKHLA, THAILAND, Thailand
- [email protected]
- PRRC contact
- FATIMAWATI MOHAMAD
Frequently asked questions
How many devices does Top Glove Medical (Thailand) Co., Ltd. have in the registry?
The registry currently lists 8 devices for Top Glove Medical (Thailand) Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Top Glove Medical (Thailand) Co., Ltd.'s devices?
Among its 8 most recently registered devices, Top Glove Medical (Thailand) Co., Ltd. has devices listed in EUDAMED (5 devices) and FDA 510(k) (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Top Glove Medical (Thailand) Co., Ltd.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Top Glove Medical (Thailand) Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Top Glove Medical (Thailand) Co., Ltd. in the registry?
The most recently registered devices listed for Top Glove Medical (Thailand) Co., Ltd. include Safety + Comfort, POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE, TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES and Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim.