FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K Number: K010211
·
Decision Feb 15, 2001
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
78
Applicant Total
63
Review Days
23
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
- STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
- K Number
- K010211
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Allegiance Healthcare Corp.
- Date Received
- January 23, 2001
- Decision Date
- February 15, 2001
- 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 Allegiance Healthcare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K023673 | AIRLIFE DEMAND NASAL CANNULA | May 2, 2003 | Substantially Equivalent |
| K023419 | TRILAMINATE DRAPES/TIBURON | Feb 11, 2003 | Substantially Equivalent |
| K024120 | MODIFICATION TO TEMNO BIOPSY NEEDLES | Jan 15, 2003 | Substantially Equivalent |
| K024292 | MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM | Jan 9, 2003 | Substantially Equivalent |
| K024102 | DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM | Dec 18, 2002 | Substantially Equivalent |
| K023425 | DRAPES WITH ABSORBENT REINFORCEMENT | Nov 6, 2002 | Substantially Equivalent |
| K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | Oct 11, 2002 | Substantially Equivalent |
| K023170 | NITRILE POWDER-FREE EXAMINATION GLOVES | Oct 9, 2002 | Substantially Equivalent |
| K023167 | BREATHABLE SURGICAL GOWN | Oct 2, 2002 | Substantially Equivalent |
| K012931 | GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM | Aug 20, 2002 | Substantially Equivalent |