Cleared Traditional

K220697 - Nitrile Patient Examination Gloves

K220697 is an FDA 510(k) clearance for Nitrile Patient Examination Gloves, manufactured by Lalan Rubbers (Pvt), Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K220697 · Lalan Rubbers (Pvt), Ltd. · General Hospital
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Sep 2022
Decision
190d
Days
Class 1
Risk

K220697 is an FDA 510(k) clearance for the Nitrile Patient Examination Gloves, Powder Free. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Lalan Rubbers (Pvt), Ltd. (Malwana, LK). The FDA issued a Cleared decision on September 15, 2022 after a review of 190 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 Lalan Rubbers (Pvt), Ltd. devices

FDA 510(k) Submission Details - K220697

510(k) Number K220697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2022
Decision Date September 15, 2022
Days to Decision 190 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
61d slower than avg
Panel avg: 129d · This submission: 190d
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 705
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K220697.
Betel Gloves Nitrile Examination Glove Powder Free
K222342 · Betel Care Sdn. Bhd. · Sep 2022
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)
K214056 · Mezorrison Medical Technology (Dongying) Co., Ltd. · Sep 2022
Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)
K222642 · Inner Mongolia Cureguard Medical Technology Co., Ltd. · Sep 2022
Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)
K220859 · Careglove Global Sdn. Bhd. · Sep 2022
Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl
K221164 · Hong Seng Gloves Sdn Bhd · Aug 2022
Nitrile Exam Gloves (Blue, Black)
K221143 · Hebei Astro Medical Supply Co., Ltd. · Aug 2022