FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇩 Indonesia
POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)
K Number: K030284
·
Decision Mar 25, 2003
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
12
Review Days
57
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Basic Information
- Device Name
- POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)
- K Number
- K030284
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pt. Smartglove Indonesia
- Date Received
- January 27, 2003
- Decision Date
- March 25, 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 Pt. Smartglove Indonesia
| K Number | Device Name | ||
|---|---|---|---|
| K133699 | POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES | Jul 18, 2014 | Substantially Equivalent |
| K101630 | POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE | Sep 7, 2010 | Substantially Equivalent |
| K101293 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) | Jul 1, 2010 | Substantially Equivalent |
| K092034 | POWDER FREE NITRILE EXAMINATION GLOVES, BLACK | Oct 19, 2009 | Substantially Equivalent |
| K041848 | POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR | Aug 20, 2004 | Substantially Equivalent |
| K040792 | POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) | Aug 12, 2004 | Substantially Equivalent |
| K040791 | POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) | Jun 3, 2004 | Substantially Equivalent |
| K030406 | NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR | Feb 27, 2003 | Substantially Equivalent |
| K030112 | POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB | Feb 27, 2003 | Substantially Equivalent |
| K022814 | MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED) | Feb 19, 2003 | Substantially Equivalent |