Cleared Traditional

Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) (K203705) - FDA 510(k) Clearance

Class I General Hospital device.

K203705 · Careplus (M) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
245d
Days
Class 1
Risk

K203705 is an FDA 510(k) clearance for the Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 .... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Careplus (M) Sdn Bhd (Seremban, MY). The FDA issued a Cleared decision on August 20, 2021 after a review of 245 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 Careplus (M) Sdn Bhd devices

Submission Details

510(k) Number K203705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2020
Decision Date August 20, 2021
Days to Decision 245 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
116d slower than avg
Panel avg: 129d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 41
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K203705.
Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
K203074 · Pt. Universal Gloves · Nov 2021
Best Glove-Latex Powder Free Examination Glove
K210253 · Bestsafe Glove Co., Ltd. · Nov 2021
Latex Examination Powder Free Gloves
K211477 · Aspen Glove Sdn. Bhd. · Sep 2021
Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)
K211620 · Shen Wei (Usa), Inc. · Aug 2021
Disposable Latex Powder Free Examination Gloves (Non-sterile)
K201576 · Pt. Universal Gloves · May 2021
Palm Care Latex Examination Powder Free Gloves
K202377 · Hi-Care Thai Gloves Co. , Ltd. · Dec 2020