FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Rhino Non-sterile Powder-Free Nitrile Exam Glove Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
K Number: K223859
·
Decision Feb 13, 2023
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
3
Review Days
52
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Basic Information
- Device Name
- Rhino Non-sterile Powder-Free Nitrile Exam Glove Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
- K Number
- K223859
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rhino Health, Inc.
- Date Received
- December 23, 2022
- Decision Date
- February 13, 2023
- Product Code
- LZA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | FDA class 1 | General Hospital |
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