Shoe And Shoe Cover, Conductive
The Shoe and Shoe Cover, Conductive is footwear or a cover designed to dissipate static electrical charges from personnel in operating rooms or other environments where explosive anesthetic gases may be present. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BWP, regulated under 21 CFR 878.4040 in the General and Plastic Surgery specialty.
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Basic Information
- Product Code
- BWP
- Device Class
- FDA class 1
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K880384 | KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT | Jun 23, 1988 | Substantially Equivalent | Kimberly-Clark Corp. |
| K831952 | SURGICAL APPAREL SHOE COVERS | Jul 12, 1983 | Substantially Equivalent | Sudreca Surgical Dressings, Inc. |
| K812105 | ANOGO DISPOSABLE SHOE COVER | Sep 11, 1981 | Substantially Equivalent | Anago, Inc. |
FEI Numbers
This FDA classification entry is associated with 55 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 55 registration numbers. Click on an entry to view related FDA registrations.