Cleared Traditional

K210253 - Best Glove-Latex Powder Free Examinatio...

K210253 is an FDA 510(k) clearance for Best Glove-Latex Powder Free Examinatio..., manufactured by Bestsafe Glove Co., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 280-day FDA review.

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

FDA 510(k) Submission Details - K210253

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.

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 264
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