FDA 510k Approval For Surgical Drapes

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Surgical drapes are used to cover areas of the body other than those that need to be examined or operated on. During a medical examination or treatment, a paper or synthetic material covering is placed over the patient’s body.

Its purpose is to provide privacy or a sterile operating field. Surgical drapes are primarily used in sterile areas to separate and isolate the surgical site from other areas of the patient’s body. They are used to prevent surgical site infections by forming a barrier between the surgical field and potential infection sources. It aids in the reduction of contamination from non-sterile to sterile areas.

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Types of surgical 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

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