Suit, Surgical
A surgical suit is a full-body protective garment worn by surgical personnel in the operating room to minimize contamination of the sterile field and reduce the risk of infection transmission. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FXO, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- FXO
- Device Class
- FDA class 1
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K914615 | BTP(TM) CENTRALINE(TM) SUIT | May 05, 1992 | Substantially Equivalent | Btp Industries, Inc. |
| K891212 | APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE | Apr 14, 1989 | Substantially Equivalent | Pro-Safe Professional Linens, Inc. |
| K882282 | SUIT, SURGICAL | Jun 23, 1988 | Substantially Equivalent | A Plus International, Inc. |
| K865022 | SURGICAL GARMENTS | Jan 12, 1987 | Substantially Equivalent | Ulti-Med Intl., Inc. |
| K831207 | SPUNGUARD SCRUB SUIT | May 16, 1983 | Substantially Equivalent | Kimberly-Clark Corp. |
| K822483 | MULTIPLE SCRUB SUIT | Sep 17, 1982 | Substantially Equivalent | Surgilite Intl., Inc. |
FEI Numbers
This FDA classification entry is associated with 113 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 113 registration numbers. Click on an entry to view related FDA registrations.