FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K Number: K113100
·
Decision Feb 6, 2012
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
9
Review Days
110
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Basic Information
- Device Name
- POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K Number
- K113100
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Maxter Glove Manufacturing Sdn Bhd
- Date Received
- October 19, 2011
- Decision Date
- February 6, 2012
- 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 Maxter Glove Manufacturing Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K172864 | Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | May 2, 2018 | Substantially Equivalent |
| K151390 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs | May 2, 2016 | Substantially Equivalent |
| K040176 | MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES | Feb 24, 2004 | Substantially Equivalent |
| K032501 | MAXTER STERILE POWDER FREE SURGICAL GLOVES | Oct 17, 2003 | Substantially Equivalent |
| K032467 | MAXTER STERILE POWDERED LATEX SURGICAL GLOVES | Oct 10, 2003 | Substantially Equivalent |
| K013554 | POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | Jan 17, 2002 | Substantially Equivalent |
| K013498 | CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | Jan 17, 2002 | Substantially Equivalent |
| K013443 | POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 | Nov 29, 2001 | Substantially Equivalent |