FDA Registration
Active
🇺🇸 United States
LATEX EXAMINATION GLOVE, POWDER FREE WITH PROTEN CONTENT LABELING CLAIM (50 ug/g or less of total extractable Protein)
Reg #: 3009964047
·
FEI: 3009964047
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ANSELL HEALTHCARE PRODUCTS LLC
- Registration Number
- 3009964047
- FEI Number
- 3009964047
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 111 Wood Ave S Suite 210
- City
- Iselin
- State
- NJ
- ZIP
- 08830
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203705
Owner / Operator
- Firm Name
- ANSELL HEALTHCARE PRODUCTS LLC
- Operator Number
- 8020065
- Address
- 2301 Robb Drive
- City
- Reno
- State
- NV
- Postal Code
- 89523
- Country
- US
- Correspondent
- Don Cronk
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2023-05-25 |
Proprietary Names
LATEX EXAMINATION GLOVE, POWDER FREE WITH PROTEN CONTENT LABELING CLAIM (50 ug/g or less of total extractable Protein)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility