FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
K Number: K163146
·
Decision Feb 13, 2017
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
78
Applicant Total
5
Review Days
96
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
- POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
- K Number
- K163146
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hebei Hongsen Plastics Technology Co, Ltd.
- Date Received
- November 9, 2016
- Decision Date
- February 13, 2017
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZC), ordered by most recent decision date.
Cardinal Health Nitrile Examination Gloves Extended Cuff
FDA 510(k)
FDA Class 1
·General Hospital
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
FDA 510(k)
FDA Class 1
·General Hospital
JR Medic
FDA 510(k)
FDA Class 1
·General Hospital
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
FDA 510(k)
FDA Class 1
·General Hospital
Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Hebei Hongsen Plastics Technology Co, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K150340 | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) | Jun 18, 2015 | Substantially Equivalent |
| K140989 | POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE) | Dec 22, 2014 | Substantially Equivalent |
| K140988 | POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE) | Aug 12, 2014 | Substantially Equivalent |
| K131440 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | Sep 25, 2013 | Substantially Equivalent |