Cleared Traditional

Disposable Latex Powder Free Examination Gloves (Non-sterile) (K201576) - FDA 510(k) Clearance

Class I General Hospital device.

K201576 · Pt. Universal Gloves · General Hospital
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May 2021
Decision
342d
Days
Class 1
Risk

K201576 is an FDA 510(k) clearance for the Disposable Latex Powder Free Examination Gloves (Non-sterile). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt. Universal Gloves (Medan, ID). The FDA issued a Cleared decision on May 19, 2021 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Pt. Universal Gloves devices

Submission Details

510(k) Number K201576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2020
Decision Date May 19, 2021
Days to Decision 342 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 129d · This submission: 342d
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 Consultant

Ammex Corporation
Sasitharan Nair

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 - LYY Latex Patient Examination Glove

All 41
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K201576.
Latex Examination Powder Free Gloves
K211477 · Aspen Glove Sdn. Bhd. · Sep 2021
Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
K203705 · Careplus (M) Sdn Bhd · Aug 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
Palm Care Latex Examination Powder Free Gloves
K202377 · Hi-Care Thai Gloves Co. , Ltd. · Dec 2020
Blue Latex Examination Powder Free Gloves
K192329 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Nov 2019
POWDER FREE LATEX EXAMINATION GLOVE
K173053 · Professional Latex Sdn Bhd · Jun 2018