Cleared Traditional

PERRY DERMAGUARD SURGICAL GLOVES (K843125) - FDA 510(k) Clearance

Class I General Hospital device.

K843125 · Perry, Div. · General Hospital

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Sep 1984

Decision

48d

Days

Class 1

Risk

K843125 is an FDA 510(k) clearance for the PERRY DERMAGUARD SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Perry, Div. (Walker, US). The FDA issued a Cleared decision on September 25, 1984 after a review of 48 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 Perry, Div. devices

Submission Details

510(k) Number	K843125 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 08, 1984
Decision Date	September 25, 1984
Days to Decision	48 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

81d faster than avg

Panel avg: 129d · This submission: 48d

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 K843125.

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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K843125

Perry, Div.

Walker, MI · US

Regulatory profile

6 submissions 6 cleared

100% clearance rate · Active in General Hospital

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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