FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE POWDERED VINYL EXAM GLOVES
K Number: K032190
·
Decision Aug 14, 2003
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
5
Review Days
28
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Basic Information
- Device Name
- DISPOSABLE POWDERED VINYL EXAM GLOVES
- K Number
- K032190
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Synmertex Co, Ltd.
- Date Received
- July 17, 2003
- Decision Date
- August 14, 2003
- Product Code
- LYZ
- 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 |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | FDA class 1 | General Hospital |
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Other Clearances by Synmertex Co, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K032172 | DISPOSABLE POWDER FREE VINYL EXAM GLOVES | Aug 14, 2003 | Substantially Equivalent |
| K031171 | DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES | May 23, 2003 | Substantially Equivalent |
| K031120 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES | May 23, 2003 | Substantially Equivalent |
| K031076 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR | May 23, 2003 | Substantially Equivalent |