FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SIME SURGICAL POWDERFREE
K Number: K954025
·
Decision Nov 15, 1995
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
558
Applicant Total
11
Review Days
79
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Basic Information
- Device Name
- SIME SURGICAL POWDERFREE
- K Number
- K954025
- 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
- Sime Health, Ltd.
- Date Received
- August 28, 1995
- Decision Date
- November 15, 1995
- 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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Other Clearances by Sime Health, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K954051 | SIME POWDERFREE PLUS | Nov 15, 1995 | Substantially Equivalent |
| K932985 | AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI | Jun 16, 1995 | Substantially Equivalent |
| K932983 | COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI) | Jul 7, 1994 | Substantially Equivalent |
| K932982 | SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI) | Jul 7, 1994 | Substantially Equivalent |
| K932984 | UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI | Jul 7, 1994 | Substantially Equivalent |
| K940797 | SIME SURGICAL LATEX GLOVE | May 9, 1994 | Substantially Equivalent |
| K931491 | SIME HEALTH SIME HYPOALLERGENIC | Oct 15, 1993 | Substantially Equivalent |
| K914276 | SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES | Dec 4, 1992 | Substantially Equivalent |
| K913813 | JIFFI CONDOM (RUBBER) CONTRACEPTIVE | Jun 1, 1992 | Substantially Equivalent |
| K913048 | SIME TRUFEEL | Sep 19, 1991 | Substantially Equivalent |