FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COVER, SHOE OPERATING ROOM
K Number: K882280
·
Decision Jun 23, 1988
Classifications
1
FEI Numbers
282
Registration Numbers
282
Same Product Code
35
Applicant Total
11
Review Days
23
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Basic Information
- Device Name
- COVER, SHOE OPERATING ROOM
- K Number
- K882280
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- A Plus International, Inc.
- Date Received
- May 31, 1988
- Decision Date
- June 23, 1988
- 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
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FLUID BARRIER BOOT KNEE & ANKLE-HIGH
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NIOMED SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by A Plus International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K213001 | Procedure Mask, Surgical Mask | May 11, 2022 | Substantially Equivalent |
| K102861 | SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) | Jan 13, 2011 | Substantially Equivalent |
| K093169 | SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) | Nov 12, 2009 | Substantially Equivalent |
| K031353 | SOLUTION FACE MASKS | Jun 19, 2003 | Substantially Equivalent |
| K882283 | BOUFFANT CAP | Jun 23, 1988 | Substantially Equivalent |
| K882281 | GOWN, ISOLATION, SURGICAL (FYC) | Jun 23, 1988 | Substantially Equivalent |
| K882284 | SURGEONS CAP | Jun 23, 1988 | Substantially Equivalent |
| K882282 | SUIT, SURGICAL | Jun 23, 1988 | Substantially Equivalent |
| K881396 | OPERATING ROOM TOWELS -STERILE & NON-STERILE | Apr 29, 1988 | Substantially Equivalent |
| K881395 | GAUZE AND LAP SPONGES -STERILE & NON-STERILE | Apr 28, 1988 | Substantially Equivalent |