FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM
K Number: K081089
·
Decision Jul 14, 2008
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
78
Applicant Total
104
Review Days
89
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Basic Information
- Device Name
- KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM
- K Number
- K081089
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kimberly-Clark Corp.
- Date Received
- April 16, 2008
- Decision Date
- July 14, 2008
- Product Code
- LZC
- 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 |
|---|---|---|---|
| LZC | Medical Glove, Specialty | FDA class 1 | General Hospital |
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