FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇩 Indonesia
POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED
K Number: K974443
·
Decision Jan 5, 1998
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
3
Review Days
41
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Basic Information
- Device Name
- POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED
- K Number
- K974443
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- P.T. Latexindo Tobaperkasa
- Date Received
- November 25, 1997
- Decision Date
- January 5, 1998
- Product Code
- LYZ
- 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 |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | FDA class 1 | General Hospital |
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