FDA Registration
Active
🇺🇸 United States
PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim
Reg #: 3010388894
·
FEI: 3010388894
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- O&M Halyard, Inc. (Mechanicsburg)
- Registration Number
- 3010388894
- FEI Number
- 3010388894
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 500 Independence Ave
- City
- Mechanicsburg
- State
- PA
- ZIP
- 17050
- 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
Repack or Relabel Medical Device