FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR
K Number: K113750
·
Decision Mar 5, 2012
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
6
Review Days
75
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Basic Information
- Device Name
- DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR
- K Number
- K113750
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Full Synergy Medical Products, Inc.
- Date Received
- December 21, 2011
- Decision Date
- March 5, 2012
- 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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Other Clearances by Full Synergy Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113749 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR | Mar 15, 2012 | Substantially Equivalent |
| K113790 | DISPOSABLE VINYL EXAM GLOVE, POWDERED | Mar 6, 2012 | Substantially Equivalent |
| K113797 | DISPOSABLE VINYL EXAM GLOVE, POWDER FREE | Mar 2, 2012 | Substantially Equivalent |
| K113710 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR | Feb 14, 2012 | Substantially Equivalent |
| K113722 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR | Feb 14, 2012 | Substantially Equivalent |