FDA 510k approval for Surgical Drapes

Surgical Drapes are used to cover the parts of the body other than those which needs to be examined or on which part to be operated. A paper or synthetic material covering which 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

510(k)

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