Cleared Traditional

K991677 - REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)

K991677 is an FDA 510(k) clearance for REGENT SKINDENDE EXAM GLOVE, manufactured by London International Group, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K991677 · London International Group, Inc. · General Hospital
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Apr 2000
Decision
331d
Days
Class 1
Risk

K991677 is an FDA 510(k) clearance for the REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDER.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by London International Group, Inc. (Dothan, US). The FDA issued a Cleared decision on April 12, 2000 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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. Elevated predicate reliance profile. 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 London International Group, Inc. devices

FDA 510(k) Submission Details - K991677

510(k) Number K991677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1999
Decision Date April 12, 2000
Days to Decision 331 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 129d · This submission: 331d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes 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 - LYY Latex Patient Examination Glove

All 445
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K991677.
POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR
K000867 · Sgmp Co., Ltd. · Apr 2000
VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K000390 · Sgmp Co., Ltd. · Apr 2000
VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K000391 · Sgmp Co., Ltd. · Apr 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
K000828 · Pamitex Industries Sdn Bhd · Apr 2000
POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING
K000671 · Sgmp Co., Ltd. · Mar 2000
VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB
K000488 · Sgmp Co., Ltd. · Mar 2000