FDA Registration
Active
🇺🇸 United States
Nitrile Exam chemotherapy gloves
Reg #: 3021286079
·
FEI: 3021286079
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- PURCEL LABS LLC
- Registration Number
- 3021286079
- FEI Number
- 3021286079
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 10537 Santa Monica Blvd. Unit 300
- City
- Los Angeles
- State
- CA
- ZIP
- 90025
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233598
Owner / Operator
- Firm Name
- PurCel Labs LLC
- Operator Number
- 10083940
- Address
- 10537 Santa Monica Blvd. Unit 300
- City
- Los Angeles
- State
- CA
- Postal Code
- 90025
- Country
- US
- Correspondent
- Doron Wipranik
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-03-06 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-03-06 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-03-06 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-03-06 |
Proprietary Names
Nitrile Exam chemotherapy gloves
Establishment Types
Repack or Relabel Medical Device