Surgical Drapes are used to cover the parts of the body other than those which need to be examined or on which part to be operated. A paper or synthetic material covering is placed over the patient’s body during medical examination or treatment.
It is designed to provide privacy or a sterile operative field. In sterile areas, surgical drapes are mainly used to ensure that the surgical site is separated and isolated from other areas of the patient’s body. They are used to prevent surgical site infections and helps to create a barrier between the surgical field and possible areas of infection. It helps in reducing contamination from non-sterile areas to sterile areas.
The following type of drapes and FDA regulation detailed below:
# |
Product | Product
code |
Regulation
Number |
Device Class
|
Submission |
1 |
Antimicrobial Drapes
|
PLY |
878.4370 |
2 | |
2 |
Cover, Barrier, Protective |
MMP |
878.4370 | 2 |
510(k) |
3 | Dental barriers and sleeves |
PEM |
878.4370 | 2 |
510(k) |
4 | Drape, Microscope, Ophthalmic |
HMW |
878.4370 | 2 |
510(k) exempt |
5 | Drape, Patient, Ophthalmic |
HMT |
878.4370 | 2 |
510(k) exempt |
6 |
Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
|
EYX |
878.4370 | 2 |
510(k) exempt |
7 | Drape, Surgical |
KKX |
878.4370
|
2 |
510(k) |
8 | Drape, Surgical, Ent |
ERY |
878.4370
|
2 |
510(k) exempt |
9 | Drape, Surgical, Exempt |
PUI |
878.4370 | 2 |
510(k) exempt |
10 | Drape, Urological, Disposable |
EYY |
878.4370 | 2 |
510(k) exempt |
11 | Pad, Kelly |
FNW |
878.4370 | 2 |
510(k) exempt |
12 |
Ring (Wound Protector), Drape Retention, Internal
|
KGW |
878.4370 | 2 |
510(k) exempt |
13 | Microbial Sealant |
NZP |
878.4370 | 2 |
510(k) |
14 | Shave Prep Kit |
OJW |
878.4370 | 2 |
510(k) exempt Enforcement discretion |