FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LATEX EXAM GLOVES (MFG. YEOU JIH INDUSTRIAL CO.)
K Number: K891841
·
Decision May 31, 1989
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
4
Review Days
64
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Basic Information
- Device Name
- LATEX EXAM GLOVES (MFG. YEOU JIH INDUSTRIAL CO.)
- K Number
- K891841
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Neo-Sigma, Inc.
- Date Received
- March 28, 1989
- Decision Date
- May 31, 1989
- 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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