Cleared Traditional

K212699 - Disposable Powder Free Polyethylene Exa...

K212699 is an FDA 510(k) clearance for Disposable Powder Free Polyethylene Exa..., manufactured by Mastermax Plastic (Huizhou), Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K212699 · Mastermax Plastic (Huizhou), Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
279d
Days
Class 1
Risk

K212699 is an FDA 510(k) clearance for the Disposable Powder Free Polyethylene Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Mastermax Plastic (Huizhou), Ltd. (Huizhou, CN). The FDA issued a Cleared decision on May 31, 2022 after a review of 279 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 Mastermax Plastic (Huizhou), Ltd. devices

FDA 510(k) Submission Details - K212699

510(k) Number K212699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2021
Decision Date May 31, 2022
Days to Decision 279 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
150d slower than avg
Panel avg: 129d · This submission: 279d
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 Consultant

Feiying Drug & Medical Consulting Technical Service Group
Tracy Che

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 684
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K212699.
PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
K220541 · O&M Halyard, Inc. · Jun 2022
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
K220547 · O&M Halyard, Inc. · Jun 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
K220488 · Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. · Jun 2022
Blue Nitrile Examination Gloves Powder Free
K212584 · Amazing Rubber Products Pvt, Ltd. · May 2022
Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
K213141 · Shen Wei (Usa), Inc. · May 2022
Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)
K220609 · Encompass Industries Sdn. Bhd. · May 2022