Cleared Traditional

K901221 - PHYSICIAN BARRIER GLOVE, SURGICAL

K901221 is an FDA 510(k) clearance for PHYSICIAN BARRIER GLOVE, manufactured by Dynamic Marketing Ent.. The device is a Class 1 General Hospital device with product code LYU cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K901221 · Dynamic Marketing Ent. · General Hospital
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Jul 1990
Decision
118d
Days
Class 1
Risk

K901221 is an FDA 510(k) clearance for the PHYSICIAN BARRIER GLOVE, SURGICAL. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Dynamic Marketing Ent. (Lake Mary, US). The FDA issued a Cleared decision on July 10, 1990 after a review of 118 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 Dynamic Marketing Ent. devices

FDA 510(k) Submission Details - K901221

510(k) Number K901221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1990
Decision Date July 10, 1990
Days to Decision 118 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
11d faster than avg
Panel avg: 129d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

LYU Device Classification - Class 1, General Controls

Product Code LYU Accessory, Surgical Apparel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.