FDA Registration
Active
🇺🇸 United States
ANSELL HEALTHCARE PRODUCTS LLC
Reg #: 3011209798
·
FEI: 3011209798
·
Expires 2026
Products
15
Proprietary Names
12
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- ANSELL HEALTHCARE PRODUCTS LLC
- Registration Number
- 3011209798
- FEI Number
- 3011209798
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2301 Robb Drive
- City
- Reno
- State
- NV
- ZIP
- 89523
- Country
- US
Regulatory Submissions
- 510(k) Number
- K982877
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 | 2022-03-14 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-01-03 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-01-03 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2007-12-05 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-05-30 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 2020-01-06 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2013-01-09 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-01-03 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2021-02-16 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2017-02-23 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2019-09-18 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2011-08-26 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-05-22 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2019-09-04 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2016-11-03 |
Proprietary Names
POWDER FREE NITRILE EXAMINATION GLOVE BLACK AND DURAL COLOR WHITE-BLUE
MICROFLEX MIDKNIGHT MK-296
GAMMEX PI PLUS GLOVE-IN-GLOVE SYSTEM TESTED FOR USE WITH CHEMOTHERAPY DRUGS
KIT TURNOVER STAT-PAC
STAT-BLOC Premium, Antimicrobial, Wide Table Sheet (90") w/ Elastic Edging at Head and Foot
PI Hybrid Micro
Supreno SE SU-690
LATEX EXAMINATION GLOVE, POWDER FREE WITH PROTEN CONTENT LABELING CLAIM (50 ug/g or less of total extractable Protein)
POWDER FREE NITRILE EXAMINATION GLOVE WHITE (colored)
Micro-Touch Royal Blue
Cobalt ® N19X
FISHER 19-041-171X
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device