Cleared Traditional

PDI PREPMASTER WET PACK VAGINAL-X21477 (K840343) - FDA 510(k) Clearance

Class I General Hospital device.

K840343 · Nice-Pak Products, Inc. · General Hospital
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Mar 1984
Decision
81d
Days
Class 1
Risk

K840343 is an FDA 510(k) clearance for the PDI PREPMASTER WET PACK VAGINAL-X21477. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Nice-Pak Products, Inc. (Mt. Vernon, US). The FDA issued a Cleared decision on March 27, 1984 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nice-Pak Products, Inc. devices

Submission Details

510(k) Number K840343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1984
Decision Date March 27, 1984
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
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.

Regulatory Peers - KGO Surgeon's Gloves

All 97
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K840343.
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K897192 · Baxter Healthcare Corp · Feb 1990
BDAC OMICRON PLUS SURGICAL GLOVES
K885271 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1989
SURGEON'S GLOVES
K842884 · Travenol Laboratories, S.A. · Nov 1984
TRIFLEX SURGEON'S GLOVES
K832448 · Travenol Laboratories, S.A. · Jan 1984
RADIATION STERILIZED SURGEON'S GLOVES
K813565 · Travenol Laboratories, S.A. · Jan 1982
SURGEON'S GLOVES
K811753 · Travenol Laboratories, S.A. · Sep 1981