Cleared Traditional

K791843 - PONCY PAK

K791843 is an FDA 510(k) clearance for PONCY PAK, manufactured by Poncy, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K791843 · Poncy, Inc. · General Hospital
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Dec 1979
Decision
91d
Days
Class 1
Risk

K791843 is an FDA 510(k) clearance for the PONCY PAK. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Poncy, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 19, 1979 after a review of 91 days - within the typical 510(k) review window.

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: 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 Poncy, Inc. devices

FDA 510(k) Submission Details - K791843

510(k) Number K791843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1979
Decision Date December 19, 1979
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

KGO Device Classification - Class 1, General Controls

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 379
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K791843.
SURGEON'S GLOVES
K811753 · Travenol Laboratories, S.A. · Sep 1981
GAMMEX SURGICAL GLOVES
K802641 · Ansell, Inc. · Dec 1980
SURGIKOS NEUTRALON BR. SURGEON'S GLOVE
K800152 · Surgikos, Inc. · Feb 1980
SUBCLAVIAN TRAY
K780419 · Concord Laboratories, Inc. · Mar 1978
DRESSING CHANGE KIT
K760912 · American Hospital Supply Corp. · Dec 1976
GLOVE, SURGEON
K760811 · Sherwood Medical Industries · Nov 1976