FDA 510(k)
FDA class 1
Substantially Equivalent
🇱🇰 Sri Lanka
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY
K Number: K122453
·
Decision Apr 5, 2013
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
14
Review Days
235
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Basic Information
- Device Name
- MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY
- K Number
- K122453
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Industrial Clothings, Ltd.
- Date Received
- August 13, 2012
- Decision Date
- April 5, 2013
- 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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Other Clearances by Industrial Clothings, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K130846 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN | Aug 8, 2013 | Substantially Equivalent |
| K122464 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE | Apr 12, 2013 | Substantially Equivalent |
| K122465 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK | Oct 16, 2012 | Substantially Equivalent |
| K033496 | MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE | Mar 9, 2004 | Substantially Equivalent |
| K023159 | MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE | Nov 12, 2002 | Substantially Equivalent |
| K022781 | MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE | Oct 8, 2002 | Substantially Equivalent |
| K021465 | MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE | May 22, 2002 | Substantially Equivalent |
| K000142 | MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE | Sep 13, 2000 | Substantially Equivalent |
| K000145 | MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE | Sep 13, 2000 | Substantially Equivalent |
| K000143 | MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED | Sep 13, 2000 | Substantially Equivalent |