FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
K Number: K090336
·
Decision Jul 1, 2009
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
5
Review Days
141
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Basic Information
- Device Name
- SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
- K Number
- K090336
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sunmax Enterprise Shanghai Co. , Ltd.
- Date Received
- February 10, 2009
- Decision Date
- July 1, 2009
- 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 Sunmax Enterprise Shanghai Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K011765 | SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE | Aug 16, 2001 | Substantially Equivalent |
| K011717 | SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES | Aug 14, 2001 | Substantially Equivalent |
| K964964 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | Feb 7, 1997 | Substantially Equivalent |
| K960746 | SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES | Jun 27, 1996 | Substantially Equivalent |