FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
K Number: K121811
·
Decision Nov 21, 2012
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
78
Applicant Total
40
Review Days
154
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Basic Information
- Device Name
- POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
- K Number
- K121811
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shen Wei (Usa), Inc.
- Date Received
- June 20, 2012
- Decision Date
- November 21, 2012
- Product Code
- LZC
- 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 |
|---|---|---|---|
| LZC | Medical Glove, Specialty | FDA class 1 | General Hospital |
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Other Clearances by Shen Wei (Usa), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161074 | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color | Nov 17, 2016 | Substantially Equivalent |
| K121528 | POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR | Sep 11, 2012 | Substantially Equivalent |
| K120890 | POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE | Aug 17, 2012 | Substantially Equivalent |
| K113233 | POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM | Mar 29, 2012 | Substantially Equivalent |
| K101436 | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) | Nov 17, 2010 | Substantially Equivalent |
| K100211 | PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA | May 11, 2010 | Substantially Equivalent |
| K092411 | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) | Oct 21, 2009 | Substantially Equivalent |
| K090194 | POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR | Jul 7, 2009 | Substantially Equivalent |
| K061756 | TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP | Apr 19, 2007 | Substantially Equivalent |
| K062919 | TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH) | Mar 20, 2007 | Substantially Equivalent |