FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
K Number: K122696
·
Decision Jan 31, 2013
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
26
Review Days
149
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Basic Information
- Device Name
- POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
- K Number
- K122696
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardinal Health, Inc.
- Date Received
- September 4, 2012
- Decision Date
- January 31, 2013
- Product Code
- LZA
- 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | FDA class 1 | General Hospital |
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Other Clearances by Cardinal Health, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K170198 | Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) | Jun 15, 2017 | Substantially Equivalent |
| K160411 | Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating | Jul 25, 2016 | Substantially Equivalent |
| K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | Jul 11, 2016 | Substantially Equivalent |
| K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) | May 12, 2016 | Substantially Equivalent |
| K121897 | PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES | Jul 27, 2012 | Substantially Equivalent |
| K120934 | PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS | May 23, 2012 | Substantially Equivalent |
| K111878 | PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES | Sep 29, 2011 | Substantially Equivalent |
| K110272 | STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG | Jun 8, 2011 | Substantially Equivalent |
| K111015 | STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING | May 6, 2011 | Substantially Equivalent |
| K110921 | NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Apr 15, 2011 | Substantially Equivalent |