FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
K Number: K121528
·
Decision Sep 11, 2012
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
40
Review Days
111
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
- K Number
- K121528
- 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
- May 23, 2012
- Decision Date
- September 11, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZA), ordered by most recent decision date.
Powder Free Nitrile Examination Gloves Non-Sterile Black
FDA 510(k)
FDA Class 1
·General Hospital
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)
FDA 510(k)
FDA Class 1
·General Hospital
Nitrile Disposable Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
FDA 510(k)
FDA Class 1
·General Hospital
Syntex Exam Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
FDA 510(k)
FDA Class 1
·General Hospital
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 |
| K121811 | POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES | Nov 21, 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 |