FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
K Number: K112012
·
Decision Mar 21, 2012
Classifications
1
FEI Numbers
444
Registration Numbers
445
Same Product Code
1158
Applicant Total
3
Review Days
252
Basic Information
- Device Name
- NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
- K Number
- K112012
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- UG HEALTHCARE (USA), INC.
- Date Received
- July 13, 2011
- Decision Date
- March 21, 2012
- Product Code
- LZA
- 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | FDA class 1 | General Hospital |
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