Cleared Traditional

K002087 - BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS) (FDA 510(k) Clearance)

Class I General Hospital device.

K002087 · Qingdao Bestex Rubber & Plastic Products Co., Ltd. · General Hospital
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Sep 2000
Decision
65d
Days
Class 1
Risk

K002087 is an FDA 510(k) clearance for the BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR L.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Qingdao Bestex Rubber & Plastic Products Co., Ltd. (Sunnyvale, US). The FDA issued a Cleared decision on September 13, 2000 after a review of 65 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 Qingdao Bestex Rubber & Plastic Products Co., Ltd. devices

Submission Details

510(k) Number K002087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2000
Decision Date September 13, 2000
Days to Decision 65 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
63d faster than avg
Panel avg: 128d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K002087.
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K221667 · New Era Medicare Sdn. Bhd. · Oct 2022