FDA Registration
Active
🇹🇭 Thailand
SAFESKIN MEDICAL & SCIENTIFIC (THAILAND), LTD.
Reg #: 9614175
·
FEI: 1000297006
·
Expires 2026
Products
4
Proprietary Names
25
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- SAFESKIN MEDICAL & SCIENTIFIC (THAILAND), LTD.
- Registration Number
- 9614175
- FEI Number
- 1000297006
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 200 MOO 8 KANCHANAVANICH ROAD, TAMBOL PRIK
- City
- SADAO Songkhla
- Country
- TH
Regulatory Submissions
- 510(k) Number
- K153708
Owner / Operator
- Firm Name
- O&M Halyard, Inc.
- Operator Number
- 10057479
- Address
- 1220 Old Alpharetta Rd, Suite 320
- City
- Alpharetta
- State
- GA
- Postal Code
- 30005
- Country
- US
- Correspondent
- Angela Bunn
US Agent
- Business Name
- O&M HALYARD, INC.
- Contact Name
- Angela Bunn
- Address
- 1220 Old Alpharetta Rd Ste 320
- City
- Alpharetta
- State
- GA
- ZIP
- 30005
- Country
- US
- [email protected]
- Phone
- 470 3647147
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2018-05-02 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2021-06-29 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2021-06-29 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-03-25 |
Proprietary Names
POLYMER PATIENT EXAM GLOVE
Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
K160709
Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves
Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves
SAFESKIN NITRILE EXAM GLOVE
Halyard STERLING* Powder-Free Nitrile Exam Gloves
EXAMINATION GLOVE, SPECIALTY
POLYMER PATIENT EXAMINATION GLOVE
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gast
PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim
Halyard Purple Nitrile Max Powder-Free Exam Gloves
Fusion Black Powder-Free Nitrile Exam Glove
SkyBreeze Zero Nitrile Powder-Free Exam Glove
Halyard Lavender Nitrile Powder-Free Exam Gloves
PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves
PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim
Sterling Nitrile Powder-Free Exam Gloves
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs And And Fenta
Halyard Purple Nitrile* Powder-Free Exam Gloves
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fenta
PATIENT EXAMINATION GLOVE, SPECIALTY
Halyard Pink Underguard Nitrile Powder-Free Exam Glove
FLEXAPRENE GREEN POWDER-FREE EXAM GLOVES
Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested With Chemotherapy Drugs
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility