Cleared Traditional

K874099 - REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE

K874099 is an FDA 510(k) clearance for REGENT DISPO STERILE BIOGEL STARCH FREE..., manufactured by Biopro, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K874099 · Biopro, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1987
Decision
67d
Days
Class 1
Risk

K874099 is an FDA 510(k) clearance for the REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Biopro, Inc. (New Rochelle, US). The FDA issued a Cleared decision on December 14, 1987 after a review of 67 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.

FDA 510(k) Submission Details - K874099

510(k) Number K874099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1987
Decision Date December 14, 1987
Days to Decision 67 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 129d · This submission: 67d
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 559
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K874099.
NATURAL-TOUCH (TM) SURGEON'S GLOVE
K872996 · Hands-On Packaging , Ltd. · Mar 1988
DAEWOO LATEX SURGICAL GLOVE
K880035 · California Ent. · Mar 1988
STERILE SURGICAL NATURAL LATEX GLOVES
K875349 · Marand Products, Inc. · Feb 1988
HI-TOUCH (TM) BRAND SURGICAL GLOVES
K874539 · Apex Medical Technologies, Inc. · Dec 1987
ANGEL LATEX SURGICAL GLOVES
K864521 · Kim Intl. Trading Co. · Dec 1986
MBK SURGEONS'(STERILE & NON-STERILE) SURG GLOVES
K864165 · Mbk Medical Gloves Co., Ltd. · Nov 1986
K874099 · REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE
Download PDF Biopro, Inc.