FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PATIENT EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)
K Number: K893072
·
Decision May 18, 1990
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
2
Review Days
400
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Basic Information
- Device Name
- PATIENT EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)
- K Number
- K893072
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Innovative Medical Suppliers
- Date Received
- April 13, 1989
- Decision Date
- May 18, 1990
- 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 Innovative Medical Suppliers
| K Number | Device Name | ||
|---|---|---|---|
| K893071 | PATIENT EXAM GLOVES (MFG. KOON SENG) | May 21, 1990 | Substantially Equivalent |