Cleared Traditional

Best Glove-Latex Powder Free Examination Glove (K210253) - FDA 510(k) Clearance

Class I General Hospital device.

K210253 · Bestsafe Glove Co., Ltd. · General Hospital
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Nov 2021
Decision
280d
Days
Class 1
Risk

K210253 is an FDA 510(k) clearance for the Best Glove-Latex Powder Free Examination Glove. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Bestsafe Glove Co., Ltd. (Muang Rayong, TH). The FDA issued a Cleared decision on November 5, 2021 after a review of 280 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Bestsafe Glove Co., Ltd. devices

Submission Details

510(k) Number K210253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2021
Decision Date November 05, 2021
Days to Decision 280 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 129d · This submission: 280d
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 41
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K210253.
Goody Gloves, Wincare, TBG Gloves
K213073 · Thai Rubber Gloves Co., Ltd. · Dec 2021
Comfortpro
K212438 · Thai Rubber Industry Company Limited · Dec 2021
Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
K203074 · Pt. Universal Gloves · Nov 2021
Latex Examination Powder Free Gloves
K211477 · Aspen Glove Sdn. Bhd. · Sep 2021
Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
K203705 · Careplus (M) Sdn Bhd · Aug 2021
Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)
K211620 · Shen Wei (Usa), Inc. · Aug 2021