FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERRY POWDER-FREE GLOVES, STYLE 45G
K Number: K923929
·
Decision Feb 10, 1993
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
558
Applicant Total
10
Review Days
189
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Basic Information
- Device Name
- PERRY POWDER-FREE GLOVES, STYLE 45G
- K Number
- K923929
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4460
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Smith & Nephew Perry
- Date Received
- August 5, 1992
- Decision Date
- February 10, 1993
- 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 Smith & Nephew Perry
| K Number | Device Name | ||
|---|---|---|---|
| K932665 | ENCORE POWDER-FREE SURGICAL GLOVES MICROPTIC | Dec 22, 1993 | Substantially Equivalent |
| K932664 | ENCORE POWDER-FREE SURGICAL GLOVES ORTHOPAEDIA | Dec 22, 1993 | Substantially Equivalent |
| K931399 | PERRY ENHANCED PROTECTION LATEX SURGICAL GLOVE | Nov 18, 1993 | Substantially Equivalent |
| K922379 | STERILE LATEX EXAMINATION GLOVES | Sep 22, 1992 | Substantially Equivalent |
| K914445 | PERRY(R) NATURAL POWDER-FREE GLOVES, STYLE 45 | Apr 22, 1992 | Substantially Equivalent |
| K914942 | PERRY(R) CUT-RESISTANT GLOVES | Jan 31, 1992 | Substantially Equivalent |
| K913402 | PERRY(R) DERMAGUARD(R) PLUS GLOVES | Oct 2, 1991 | Substantially Equivalent |
| K911633 | PERRY(R) ENCORE CHEMOTHERAPY GLOVE | May 9, 1991 | Substantially Equivalent |
| K905537 | PERRY XTENDA CUFF SURGICAL GLOVES | Jan 11, 1991 | Substantially Equivalent |