FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHOE COVERS
K Number: K874064
·
Decision Nov 4, 1987
Classifications
1
FEI Numbers
282
Registration Numbers
282
Same Product Code
35
Applicant Total
11
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SHOE COVERS
- K Number
- K874064
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Interpro Intl., Inc.
- Date Received
- October 5, 1987
- Decision Date
- November 4, 1987
- Product Code
- FXP
- 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 |
|---|---|---|---|
| FXP | Cover, Shoe, Operating-Room | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FXP), ordered by most recent decision date.
PRIMED SHOE COVERS, PRIMED HEAD COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FAR-EAST SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CONVERTORS IMPERVIOUS SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SHOE COVER, NON-STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIOMED SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Interpro Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890968 | VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX) | Jul 31, 1989 | Substantially Equivalent |
| K890891 | LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL) | Jul 14, 1989 | Substantially Equivalent |
| K891642 | PATIENT EXAMINATION GLOVES (LATEX) | Jul 14, 1989 | Substantially Equivalent |
| K891438 | PATIENT EXAMINATION GLOVES (LATEX) | May 31, 1989 | Substantially Equivalent |
| K891440 | PATIENT EXAMINATION GLOVES (LATEX) | May 31, 1989 | Substantially Equivalent |
| K881374 | SURGEONS GLOVES | Aug 5, 1988 | Substantially Equivalent |
| K874067 | GUAZE SPONGES | Dec 14, 1987 | Substantially Equivalent |
| K874766 | INTERPRO INT'L, INC. ISOLATION GOWN | Dec 10, 1987 | Substantially Equivalent |
| K874066 | SURGICAL CAPS | Nov 4, 1987 | Substantially Equivalent |
| K874065 | LAPAROTOMY SPONGES | Nov 4, 1987 | Substantially Equivalent |