FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇪 Ireland
BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM
K Number: K121926
·
Decision Sep 20, 2012
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
78
Applicant Total
9
Review Days
80
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Basic Information
- Device Name
- BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM
- K Number
- K121926
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Northstar Healthcare Holdings
- Date Received
- July 2, 2012
- Decision Date
- September 20, 2012
- Product Code
- LZC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZC | Medical Glove, Specialty | FDA class 1 | General Hospital |
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Other Clearances by Northstar Healthcare Holdings
| K Number | Device Name | ||
|---|---|---|---|
| K122727 | BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE | Feb 22, 2013 | Substantially Equivalent |
| K122788 | TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O | Jan 17, 2013 | Substantially Equivalent |
| K123026 | TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO | Nov 16, 2012 | Substantially Equivalent |
| K122998 | BLUE POWDERED NITRILE EXAMINATION GLOVE | Nov 6, 2012 | Substantially Equivalent |
| K121947 | ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES | Sep 10, 2012 | Substantially Equivalent |
| K121529 | BLACK NITRILE POWDER-FREE EXAMINATION GLOVES | Jul 12, 2012 | Substantially Equivalent |
| K121464 | BLUE POWER FREE NITRILE EXAMINATION GLOVE | Jul 5, 2012 | Substantially Equivalent |
| K121506 | UTB BLUE POWDER FREE NITRILE | Jul 3, 2012 | Substantially Equivalent |