Cleared Traditional

K212535 - Nitrile Powder Free Blue Examination Gloves

K212535 is an FDA 510(k) clearance for Nitrile Powder Free Blue Examination Gloves, manufactured by Mah Sing Healthcare Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K212535 · Mah Sing Healthcare Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
115d
Days
Class 1
Risk

K212535 is an FDA 510(k) clearance for the Nitrile Powder Free Blue Examination Gloves, Non-Sterile. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Mah Sing Healthcare Sdn. Bhd. (Kuala Lumpur, MY). The FDA issued a Cleared decision on December 4, 2021 after a review of 115 days - within the typical 510(k) review window.

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 Mah Sing Healthcare Sdn. Bhd. devices

FDA 510(k) Submission Details - K212535

510(k) Number K212535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2021
Decision Date December 04, 2021
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
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 K212535.
ComfortPro Blue Nitrile Examination Gloves Powder Free
K212850 · Thai Rubber Industry Company Limited · Dec 2021
Nitrile Examination Gloves
K212922 · Hsk Medical Apparatus Foshan China Co., Ltd. · Dec 2021
Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
K213371 · Anhui Xinyisheng Medical Technology Co.,Ltd · Dec 2021
Nitrile disposable examination gloves
K212578 · Xingyu Medical Tech Co., Ltd. · Dec 2021
powder free nitrile examination glove - white, non-sterile
K212802 · Hong Seng Gloves Sdn Bhd · Dec 2021
Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K212789 · 5r Med Instruments (Chengdu) Co., Ltd. · Dec 2021