FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇩 Indonesia
POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
K Number: K981064
·
Decision Nov 5, 1998
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
11
Review Days
227
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Basic Information
- Device Name
- POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
- K Number
- K981064
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- P.T. Irama Dinamika Latex
- Date Received
- March 23, 1998
- Decision Date
- November 5, 1998
- 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 P.T. Irama Dinamika Latex
| K Number | Device Name | ||
|---|---|---|---|
| K984449 | NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM | Mar 19, 1999 | Substantially Equivalent |
| K980848 | HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED | Apr 28, 1998 | Substantially Equivalent |
| K972306 | POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE | Sep 12, 1997 | Substantially Equivalent |
| K965155 | LATEX EXAM GLOVES | Mar 5, 1997 | Substantially Equivalent |
| K962518 | NITRILE COPOLYMER PATIENT EXAMINATION GLOVES | Dec 19, 1996 | Substantially Equivalent |
| K963771 | CHLOROPRENE EXAM GLOVES | Dec 19, 1996 | Substantially Equivalent |
| K960315 | FLAVORED LATEX PATIENT EXAMINATION | Nov 20, 1996 | Substantially Equivalent |
| K953462 | PATIENT EXAMINATION GLOVES | Jan 4, 1996 | Substantially Equivalent |
| K941787 | LATEX EXAM GLOVES | Oct 19, 1994 | Substantially Equivalent |
| K913776 | PATIENT EXAMINATION GLOVES | Nov 7, 1991 | Substantially Equivalent |