FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
POWDER FREE NITRILE EXAMINATION GLOVES
K Number: K111328
·
Decision Jul 15, 2011
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
18
Review Days
65
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Basic Information
- Device Name
- POWDER FREE NITRILE EXAMINATION GLOVES
- K Number
- K111328
- 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
- May 11, 2011
- Decision Date
- July 15, 2011
- 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 |
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Other Clearances by Gx Corporation Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K200915 | Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs | Jul 9, 2021 | Substantially Equivalent |
| K183354 | Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate | Jun 20, 2019 | 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 |
| K091151 | POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN | Jun 1, 2009 | Substantially Equivalent |