FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD)
K Number: K903847
·
Decision Jan 31, 1991
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
3
Review Days
163
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Basic Information
- Device Name
- VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD)
- K Number
- K903847
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Zest Mark Industrial Co., Ltd.
- Date Received
- August 21, 1990
- Decision Date
- January 31, 1991
- 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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