Cleared Traditional

K042645 - POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING (FDA 510(k) Clearance)

Class I General Hospital device.

K042645 · Qingdao Bestex Rubber & Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
60d
Days
Class 1
Risk

K042645 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE V.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Qingdao Bestex Rubber & Plastic Products Co., Ltd. (Santa Clara, US). The FDA issued a Cleared decision on November 26, 2004 after a review of 60 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 K042645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2004
Decision Date November 26, 2004
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 128d · This submission: 60d
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 K042645.
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
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K221667 · New Era Medicare Sdn. Bhd. · Oct 2022