FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
K Number: K113233
·
Decision Mar 29, 2012
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
558
Applicant Total
40
Review Days
148
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Basic Information
- Device Name
- POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
- K Number
- K113233
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4460
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shen Wei (Usa), Inc.
- Date Received
- November 2, 2011
- Decision Date
- March 29, 2012
- Product Code
- KGO
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | FDA class 1 | General, Plastic Surgery |
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| K061756 | TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP | Apr 19, 2007 | Substantially Equivalent |
| K062919 | TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH) | Mar 20, 2007 | Substantially Equivalent |