FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Barrier Supreme Sterilization Wrapper
K Number: K162162
·
Decision Nov 4, 2016
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
23
Review Days
94
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Basic Information
- Device Name
- Barrier Supreme Sterilization Wrapper
- K Number
- K162162
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Standard Textile Co., Inc.
- Date Received
- August 2, 2016
- Decision Date
- November 4, 2016
- Product Code
- FRG
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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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 |
| 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 |
| K010799 | COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) | Jun 7, 2001 | Substantially Equivalent |