FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE
K Number: K010231
·
Decision Feb 9, 2001
Classifications
1
FEI Numbers
169
Registration Numbers
169
Same Product Code
1953
Applicant Total
1
Review Days
16
Basic Information
- Device Name
- JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE
- K Number
- K010231
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- JK GLOVES SDN. BHD.
- Date Received
- January 24, 2001
- Decision Date
- February 9, 2001
- Product Code
- LYY
- 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | FDA class 1 | General Hospital |
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