Cleared Traditional

K210249 - Best Glove-Nitrile Powder Free Examinat...

K210249 is an FDA 510(k) clearance for Best Glove-Nitrile Powder Free Examinat..., manufactured by Bestsafe Glove Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K210249 · Bestsafe Glove Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
269d
Days
Class 1
Risk

K210249 is an FDA 510(k) clearance for the Best Glove-Nitrile Powder Free Examination Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Bestsafe Glove Co., Ltd. (Muang Rayong, TH). The FDA issued a Cleared decision on October 25, 2021 after a review of 269 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 - K210249

510(k) Number K210249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2021
Decision Date October 25, 2021
Days to Decision 269 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
140d slower than avg
Panel avg: 129d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 682
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K210249.
Examination gloves -Type C (Nitrile gloves)
K212290 · Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · Oct 2021
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
K211604 · Shanxi Hongjin Plastic Technology Co., Ltd. · Oct 2021
Disposable Medical Nitrile Examination Gloves
K212363 · Lanhuo Medical Technology (Jiangsu) Co.,Ltd · Oct 2021
Disposable Nitrile Examination Glove
K212401 · Inner Mongolia Cureguard Medical Technology Co., Ltd. · Oct 2021
Medical Examination Gloves
K212311 · Guangzhou Junda Gloves Co., Ltd. · Oct 2021
Nitrile Examination Gloves
K210706 · Niujian Technology Co., Ltd. · Oct 2021