FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN
K Number: K091151
·
Decision Jun 1, 2009
Classifications
1
FEI Numbers
444
Registration Numbers
445
Same Product Code
1158
Applicant Total
16
Review Days
42
Basic Information
- Device Name
- POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN
- K Number
- K091151
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- GX CORPORATION SDN BHD
- Date Received
- April 20, 2009
- Decision Date
- June 1, 2009
- 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.
Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
FDA 510(k)
FDA Class 1
·General Hospital
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
FDA 510(k)
FDA Class 1
·General Hospital
Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)
FDA 510(k)
FDA Class 1
·General Hospital
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles
FDA 510(k)
FDA Class 1
·General Hospital
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
FDA 510(k)
FDA Class 1
·General Hospital
Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by GX CORPORATION SDN BHD
| K Number | Device Name | ||
|---|---|---|---|
| K111328 | POWDER FREE NITRILE EXAMINATION GLOVES | Jul 15, 2011 | Substantially Equivalent |
| K102074 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) | Nov 2, 2010 | Substantially Equivalent |
| K101828 | POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Oct 4, 2010 | Substantially Equivalent |
| K091851 | STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Dec 28, 2009 | Substantially Equivalent |
| K092072 | POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE | Nov 4, 2009 | Substantially Equivalent |
| K091643 | POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Nov 2, 2009 | Substantially Equivalent |
| K092200 | POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) | Sep 16, 2009 | Substantially Equivalent |
| K090412 | POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE). | Jun 1, 2009 | Substantially Equivalent |
| K083717 | POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK | Jan 30, 2009 | Substantially Equivalent |
| K081315 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) | Aug 11, 2008 | Substantially Equivalent |