FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED)
K Number: K983614
·
Decision Feb 4, 1999
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
3
Review Days
113
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Basic Information
- Device Name
- UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED)
- K Number
- K983614
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Healthcare Products (M) Sdn Bhd
- Date Received
- October 14, 1998
- Decision Date
- February 4, 1999
- 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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