FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PATIENT EXAM GLOVES (MFG. XIAN WELFARE LATEX )
K Number: K892023
·
Decision May 25, 1989
Classifications
1
FEI Numbers
169
Registration Numbers
169
Same Product Code
1953
Applicant Total
7
Review Days
56
Basic Information
- Device Name
- PATIENT EXAM GLOVES (MFG. XIAN WELFARE LATEX )
- K Number
- K892023
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- BRILLIANT RAY INTL., INC.
- Date Received
- March 30, 1989
- Decision Date
- May 25, 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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Other Clearances by BRILLIANT RAY INTL., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K892022 | PATIENT EXAM GLOVES (MFG. YU HUA LATEX FACTORY) | May 25, 1989 | Substantially Equivalent |
| K892025 | PATIENT EXAM GLOVES (MFG. BEIJING LATEX FACTORY) | May 25, 1989 | Substantially Equivalent |
| K892024 | PATIENT EXAM GLOVES (MFG. CHAGAN TANG CAPITOL) | May 25, 1989 | Substantially Equivalent |
| K892109 | PATIENT EXAMINATION GLOVES (LATEX) | May 4, 1989 | Substantially Equivalent |
| K891740 | PATIENT EXAM GLOVES (LATEX) MFG. TIANJIN KANG BAO | Apr 14, 1989 | Substantially Equivalent |
| K891739 | PATIENT EXAM GLOVE (LATEX) MFG. TIANJIN JI COUNTY | Apr 14, 1989 | Substantially Equivalent |