FDA Registration
Active
🇺🇸 United States
PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim
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
- K220547
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 |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2022-06-03 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2022-06-03 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2022-06-03 |
Proprietary Names
PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198