KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP— 510(k) K881471

Clearance details

Applicant

Kimberly-Clark Corp.

Product code

Code FRG

Device class

Class 2

Regulation

21 CFR 880.6850

Advisory panel

General Hospital

Date received

1988-04-07

Decision date

1988-08-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Roswell, GA, US

• K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology +3 more2026-07-02
• K252823 — Dukal Crepe Paper Sterilization Wrap2026-05-28
• K253454 — HALYARD* ONE-STEP* Sterilization Wrap +3 more2026-05-18
• K251347 — Sterilization Pouch/Roll2026-01-28
• K251177 — Self-Seal Sterilization Pouch and Roll2025-12-12

• K140963 — KIMGUARD SMART-FOLD STERILIZATION WRAP2014-11-10
• K141294 — U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS2014-08-25
• K131879 — KC 300 SURGICAL MASK2013-12-20
• K131841 — KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE2013-11-07
• K131254 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE2013-08-20

Other

3

Total

3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0995-2013 — KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.Class II·Terminated·Kimberly-Clark Corporation·20130306

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K881471.