Cleared Traditional

K964317 - FOXELL, MEDIGUARD, PLUS MULTIPLE BRAND NAMES

K964317 is an FDA 510(k) clearance for FOXELL, manufactured by Nantong Ruchang Latex Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K964317 · Nantong Ruchang Latex Products Co., Ltd. · General Hospital
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Jan 1997
Decision
87d
Days
Class 1
Risk

K964317 is an FDA 510(k) clearance for the FOXELL, MEDIGUARD, PLUS MULTIPLE BRAND NAMES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Nantong Ruchang Latex Products Co., Ltd. (Baltimore, US). The FDA issued a Cleared decision on January 24, 1997 after a review of 87 days - a notably fast clearance cycle.

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: 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 Nantong Ruchang Latex Products Co., Ltd. devices

FDA 510(k) Submission Details - K964317

510(k) Number K964317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1996
Decision Date January 24, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
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 678
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K964317.
AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN)
K963866 · Supertex Industrial, S.A. DE C.V. · Feb 1997
AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN)
K962737 · Supertex Industrial, S.A. DE C.V. · Feb 1997
MEDTEXX
K963331 · Regalfield Sdn. Bhd. · Jan 1997
DERLIN
K964817 · Derlin Company , Ltd. · Jan 1997
DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM
K955425 · Dash Medical Gloves Sdn Bhd · Dec 1996
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
K964563 · Omni Sales Corp. · Dec 1996