FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇩 Indonesia
PRE-POWDERED NITRILE EXAMINATION GLOVES
K Number: K974442
·
Decision Jan 5, 1998
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
7
Applicant Total
3
Review Days
41
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Basic Information
- Device Name
- PRE-POWDERED NITRILE EXAMINATION GLOVES
- K Number
- K974442
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- P.T. Latexindo Tobaperkasa
- Date Received
- November 25, 1997
- Decision Date
- January 5, 1998
- Product Code
- LZY
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | FDA class 2 | Orthopedic |
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