Cleared Traditional

K891820 - DISPOSABLE MEDICAL GOWNS

K891820 is an FDA 510(k) clearance for DISPOSABLE MEDICAL GOWNS, manufactured by Bioshield, Inc.. The device is a Class 2 General Hospital device with product code FYB cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K891820 · Bioshield, Inc. · General Hospital
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Jul 1989
Decision
126d
Days
Class 2
Risk

K891820 is an FDA 510(k) clearance for the DISPOSABLE MEDICAL GOWNS. Classified as Gown, Patient (product code FYB), Class II - Special Controls.

Submitted by Bioshield, Inc. (Modesto, US). The FDA issued a Cleared decision on July 24, 1989 after a review of 126 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bioshield, Inc. devices

FDA 510(k) Submission Details - K891820

510(k) Number K891820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date July 24, 1989
Days to Decision 126 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 129d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYB Device Classification - Class 2, Special Controls

Product Code FYB Gown, Patient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.