FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
K Number: K014134
·
Decision Jan 22, 2002
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
33
Applicant Total
3
Review Days
36
Basic Information
- Device Name
- POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
- K Number
- K014134
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SUPERGRADE HEALTHCARE PRODUCTS SDN. BHD.
- Date Received
- December 17, 2001
- Decision Date
- January 22, 2002
- Product Code
- FMC
- 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 |
|---|---|---|---|
| FMC | Patient Examination Glove | FDA class 1 | General Hospital |
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