FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
K Number: K010799
·
Decision Jun 7, 2001
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
23
Review Days
83
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Basic Information
- Device Name
- COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
- K Number
- K010799
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Standard Textile Co., Inc.
- Date Received
- March 16, 2001
- Decision Date
- June 7, 2001
- Product Code
- FYA
- 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 |
|---|---|---|---|
| FYA | Gown, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Standard Textile Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241214 | ProPel SG3 Surgical Gown | Sep 10, 2024 | Substantially Equivalent |
| K172207 | Standard Supreme Sterilization Wrapper | Aug 25, 2017 | Substantially Equivalent |
| K162162 | Barrier Supreme Sterilization Wrapper | Nov 4, 2016 | Substantially Equivalent |
| K060181 | COMPE1 1 -PLY SURGICAL GOWNS | Mar 7, 2006 | Substantially Equivalent |
| K041653 | COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS | Jul 1, 2005 | Substantially Equivalent |
| K041540 | COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS | May 5, 2005 | Substantially Equivalent |
| K041539 | COMPEL SURGICAL GOWNS | Apr 28, 2005 | Substantially Equivalent |
| K041541 | COMPEL MLR SURGICAL GOWNS | Mar 16, 2005 | Substantially Equivalent |
| K012268 | TRIMAX | Dec 3, 2001 | Substantially Equivalent |
| K012807 | MODIFICATION TO: COMPEL SURGICAL DRAPES | Oct 11, 2001 | Substantially Equivalent |