DRAPE SURGICAL UTILITY DRAPE STERILE
Device Facts
| Record ID | K843496 |
|---|---|
| Device Name | DRAPE SURGICAL UTILITY DRAPE STERILE |
| Applicant | Busse Hospital Disposables, Inc. |
| Product Code | KKX · General, Plastic Surgery |
| Decision Date | Oct 31, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4370 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.
Special Controls
*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
