Cleared Traditional

K021058 - SYNTEX POWDER-FREE MULTI-PLY LATEX EXAM...

K021058 is an FDA 510(k) clearance for SYNTEX POWDER-FREE MULTI-PLY LATEX EXAM..., manufactured by Syntex Healthcare 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 42-day FDA review.

K021058 · Syntex Healthcare Products Co., Ltd. · General Hospital
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May 2002
Decision
42d
Days
Class 1
Risk

K021058 is an FDA 510(k) clearance for the SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Syntex Healthcare Products Co., Ltd. (Xinji City, Hebei Province, CN). The FDA issued a Cleared decision on May 14, 2002 after a review of 42 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 Syntex Healthcare Products Co., Ltd. devices

FDA 510(k) Submission Details - K021058

510(k) Number K021058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2002
Decision Date May 14, 2002
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 268
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K021058.
POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)
K022601 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
K020818 · Allegiance Healthcare Corp. · Jul 2002
STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES
K021521 · Smart Glove Corp. Sdn Bhd · Jul 2002
POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS
K013267 · Siam Sempermed Corp., Ltd. · Mar 2002
SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT
K014110 · Siam Sempermed Corp., Ltd. · Feb 2002
SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E
K014112 · Siam Sempermed Corp., Ltd. · Feb 2002