FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
K Number: K980827
·
Decision May 4, 1998
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
4
Applicant Total
4
Review Days
62
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
- K Number
- K980827
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tucker & Associates
- Date Received
- March 3, 1998
- Decision Date
- May 4, 1998
- Product Code
- LZB
- 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 |
|---|---|---|---|
| LZB | Finger Cot | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZB), ordered by most recent decision date.
ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
FDA 510(k)
FDA Class 1
·General Hospital
PERCUGUARD
FDA 510(k)
FDA Class 1
·General Hospital
BETHEL PLUS MULTIPLE NAMES
FDA 510(k)
FDA Class 1
·General Hospital
LATEX FINGER COTS
FDA 510(k)
FDA Class 1
·General Hospital