FDA Registration
Active
🇺🇸 United States
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs And And Fenta
Reg #: 3014421917
·
FEI: 3014421917
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- O&M Halyard, Inc.
- Registration Number
- 3014421917
- FEI Number
- 3014421917
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1220 Old Alpharetta Rd Ste 320
- City
- Alpharetta
- State
- GA
- ZIP
- 30005
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202622
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2021-02-19 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2021-02-19 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2021-02-19 |
Proprietary Names
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs And And Fenta
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198