FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K Number: K051378
·
Decision Aug 3, 2005
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
11
Review Days
69
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 EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
- K Number
- K051378
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medline
- Date Received
- May 26, 2005
- Decision Date
- August 3, 2005
- 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 Medline
| K Number | Device Name | ||
|---|---|---|---|
| K120156 | PUREIMAGE ULTRASOUND TRANSMISSION GEL | Feb 8, 2012 | Substantially Equivalent |
| K010825 | MEDLINE STERISET STERILIZATION CONTAINER | May 8, 2001 | Substantially Equivalent |
| K990463 | MEDLINE EXCEL WHEELCHAIRS | Mar 15, 1999 | Substantially Equivalent |
| K970282 | MEDLINE CIRCUMCISION TRAY | Mar 6, 1997 | Substantially Equivalent |
| K963504 | MEDLINE OPEN END FINGER CONTROL MITT | Oct 29, 1996 | Substantially Equivalent |
| K963452 | MEDLINE ZIPPER SLEEVED VEST | Oct 18, 1996 | Substantially Equivalent |
| K951736 | LOCK-UP | Jul 5, 1995 | Substantially Equivalent |
| K932033 | LAPAROSCOPIC SURGERY INSTRUMENTS | Jun 19, 1995 | Substantially Equivalent |
| K932060 | MARTIN COLD LIGHT FOUNTAIN | Mar 30, 1994 | Substantially Equivalent |
| K915502 | MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES | Apr 29, 1992 | Substantially Equivalent |