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Surgical Drapes

by Procter & Gamble Mfg. Co. 510(k)

Active United States

510(k) K844802

Overview

Surgical drapes are devices used to cover and isolate a surgical site, providing a sterile barrier during operative procedures. This device is identified by the product code KKX and was cleared via the FDA 510(k) process under K844802.

The device was submitted by Procter & Gamble Mfg. Co. and received FDA clearance on January 14, 1985, following a traditional 510(k) review. It is classified under the General and Plastic Surgery advisory committee and is supplied as a non-sterile or sterile drape depending on formulation, though specific sterility, size, reusability, or MRI safety details are not provided in the data.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844802 Date14 Jan 1985ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KKX
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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