Cleared Traditional

Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K182600) - FDA 510(k) Clearance

Class I General Hospital device.

K182600 · Better Care Plastic Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
70d
Days
Class 1
Risk

K182600 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Better Care Plastic Technology Co., Ltd. (Shenze County, CN). The FDA issued a Cleared decision on November 30, 2018 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Better Care Plastic Technology Co., Ltd. devices

Submission Details

510(k) Number K182600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2018
Decision Date November 30, 2018
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Hongray USA Medical Products, Inc.
Kathy Liu

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 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K182600.
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
K182241 · Sri Trang Gloves (Thailand) Co., Ltd. · Mar 2019
Powder Free Nitrile Patient Examination Gloves, Blue Color
K181106 · Jiangsu Dongxin Medical Technology Co., Ltd. · Jan 2019
Nitrile Glove Powder Free White
K183068 · Haining Medical Products Co., Ltd. · Dec 2018
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K181857 · Kossan International Sdn Bhd · Nov 2018
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
K180645 · Hartalega Sdn Bhd · Nov 2018
Nitrile Glove Powder Free Black
K182528 · Haining Medical Products Co., Ltd. · Nov 2018