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	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