FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
SUPERGLOVES POWDERED NITRILE
K Number: K980966
·
Decision Jul 22, 1998
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
9
Review Days
128
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Basic Information
- Device Name
- SUPERGLOVES POWDERED NITRILE
- K Number
- K980966
- 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 Sdn Bhd
- Date Received
- March 16, 1998
- Decision Date
- July 22, 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 Supermax Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K013774 | CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA | Mar 5, 2002 | Substantially Equivalent |
| K993865 | GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES | Jan 20, 2000 | Substantially Equivalent |
| K993864 | COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES | Jan 20, 2000 | Substantially Equivalent |
| K993258 | SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES | Oct 27, 1999 | Substantially Equivalent |
| K991415 | SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES | May 26, 1999 | Substantially Equivalent |
| K980494 | SUPERGLOVES | Jun 9, 1998 | Substantially Equivalent |
| K915251 | PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC | Jan 22, 1993 | Substantially Equivalent |
| K892287 | PATIENT EXAMINATION GLOVES (LATEX) | Jan 10, 1990 | Substantially Equivalent |