PHOENIX DRAPES WITH MICROBAN— 510(k) K890917

Clearance details

Applicant

Phoenix Medical Technology, Inc.

Product code

Code KGX

Device class

Class 1

Regulation

21 CFR 880.5240

Advisory panel

General Hospital

Date received

1989-02-23

Decision date

1989-08-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fort Worth, TX, US

• K001240 — SERAGARD INJECTION PATCH2000-06-21
• K983368 — CARE BAND ANTIBACTERIAL BANDAGES1999-02-17
• K972914 — SYVEK PATCH1997-12-22
• K943314 — ADHESIVE BANDAGES WITH OTC DRUG1996-01-17
• K952606 — TARGETT PATCH1995-12-21

• K000223 — NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE2000-04-14
• K945045 — PATIENT EXAINATION GLOVES1995-01-02
• K905031 — PATIENT EXAMINATION GLOVES1991-01-18
• K900453 — MODIFIED SINGLE USE LATEX EXAMINATION GLOVES1990-02-13
• K900454 — MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES1990-02-13

Injury

1,590

Malfunction

1,357

Other

3

Total

2,950

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 →