FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
K Number: K024083
·
Decision Jan 10, 2003
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
6
Review Days
30
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Basic Information
- Device Name
- GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
- K Number
- K024083
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Supermax Glove Manufacturing Sdn Bhd
- Date Received
- December 11, 2002
- Decision Date
- January 10, 2003
- 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 Supermax Glove Manufacturing Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K014230 | STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) | Mar 13, 2002 | Substantially Equivalent |
| K013953 | AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM | Feb 26, 2002 | Substantially Equivalent |
| K013589 | CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA | Jan 8, 2002 | Substantially Equivalent |
| K010198 | STERILE POWDERED LATEX SURGEON GLOVES | Feb 23, 2001 | Substantially Equivalent |
| K000644 | SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES | Mar 17, 2000 | Substantially Equivalent |