FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES)
K Number: K900352
·
Decision Mar 27, 1990
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
14
Review Days
63
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Basic Information
- Device Name
- LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES)
- K Number
- K900352
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Sinochem (Usa), Inc.
- Date Received
- January 23, 1990
- Decision Date
- March 27, 1990
- 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 Sinochem (Usa), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K900980 | LATEX EXAMINATION GLOVES | Jun 1, 1990 | Substantially Equivalent |
| K901398 | LATEX SURGEON GLOVES | May 16, 1990 | Substantially Equivalent |
| K893882 | LATEX EXAMINATION GLOVES | Sep 21, 1989 | Substantially Equivalent |
| K893694 | LATEX EXAM GLOVES(MFG: SHANG HAI RONGTONG LATEX) | Aug 10, 1989 | Substantially Equivalent |
| K892154 | PATIENT EXAM GLOVES (MFG. LIAONING FOREIGN TRADE) | Jul 14, 1989 | Substantially Equivalent |
| K892158 | PATIENT EXAM GLOVES (MFG. SUZHOU LATEX FACTORY) | Jul 14, 1989 | Substantially Equivalent |
| K892153 | PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS) | Jul 14, 1989 | Substantially Equivalent |
| K892156 | PATIENT EXAM GLOVES (MFG. NO. 1 FACTORY, WUHAN) | Jul 14, 1989 | Substantially Equivalent |
| K892151 | PATIENT EXAM GLOVES (MFG. GUILIN LATEX FACTORY) | Jul 14, 1989 | Substantially Equivalent |
| K892155 | PATIENT EXAM GLOVES (MFG. HUBEI TIANMEN LATEX) | Jul 14, 1989 | Substantially Equivalent |