DISPOSABLE MEDICAL GOWNS— 510(k) K891820

Substantially Equivalent

Bioshield, Inc.

FDA 510(k) clearance K891820 for DISPOSABLE MEDICAL GOWNS, Substantially Equivalent on 1989-07-24. Applicant: Bioshield, Inc.. Device class: 2.

Clearance details

Applicant: Bioshield, Inc.
Product code: Code FYB
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1989-03-20
Decision date: 1989-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Modesto, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FYB

K911921 — DISPOSABLE ISOLATION GOWN1991-05-13
K891053 — DENTAL BIB1989-04-12
K803171 — PROCEDURE & RECOVERY PATIENT SUIT1981-03-04
K801570 — SHIELD DISP. PATIENTS PONCHO GOWNS1980-07-28
K771929 — PEDIATRICS GOWN1977-11-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.