KERLIX MD ANTIMICROBIAL GAUZE DRESSING— 510(k) K990530

Clearance details

Applicant

The Kendall Company, L.P.

Product code

Code NAD

Device class

Class 1

Regulation

21 CFR 878.4020

Advisory panel

General, Plastic Surgery

Date received

1999-02-19

Decision date

2000-01-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mansfield, MA, US

• K254246 — LT Antibacterial Foam with Silver Dressing2026-09-10
• K102403 — SAM CHEST SEAL WITH VAVLE2011-03-03
• K091133 — APLION TOPICAL CARE SYSTEM2009-05-20
• K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)2008-06-17
• K080524 — CENTURION SORBAVIEW OTC2008-04-23

• K992079 — KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 73251999-09-29

Injury

431

Malfunction

11,935

Other

1

Total

12,367

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-0013-2019 — Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.Class II·Terminated·COVIDIEN LLC·20180801
• Z-0014-2019 — Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.Class II·Terminated·COVIDIEN LLC·20180801
• Z-0015-2019 — Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.Class II·Terminated·COVIDIEN LLC·20180801
• Z-0016-2019 — Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.Class II·Terminated·COVIDIEN LLC·20180801
• Z-0017-2019 — Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.Class II·Terminated·COVIDIEN LLC·20180801
• Z-0018-2019 — Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.Class II·Terminated·COVIDIEN LLC·20180801

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K990530.