BIO-GUARD O.R. SCRUB PREP TRAY— 510(k) K905004

Name: FDA 510(k) clearance K905004
Creator: U.S. Food and Drug Administration
Published: 1991-02-21

Substantially Equivalent

Network Medical Systems, Inc.

FDA 510(k) clearance K905004 for BIO-GUARD O.R. SCRUB PREP TRAY, Substantially Equivalent on 1991-02-21. Applicant: Network Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Network Medical Systems, Inc.
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1990-11-07
Decision date: 1991-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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K921664 — BIO-GUARD LATEX SURGICAL GLOVES1992-09-23
K905003 — BIO-GUARD SHAVE PREP TRAY1990-12-28

Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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 →

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