Cleared Traditional

Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) (K203074) - FDA 510(k) Clearance

Class I General Hospital device.

K203074 · Pt. Universal Gloves · General Hospital
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Nov 2021
Decision
406d
Days
Class 1
Risk

K203074 is an FDA 510(k) clearance for the Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examina.... 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 November 19, 2021 after a review of 406 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Pt. Universal Gloves devices

Submission Details

510(k) Number K203074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2020
Decision Date November 19, 2021
Days to Decision 406 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
277d slower than avg
Panel avg: 129d · This submission: 406d
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 K203074.
Latex Examination Gloves, Powder Free
K213509 · Shandong Intco Medical Products Co, Ltd. · Apr 2022
Goody Gloves, Wincare, TBG Gloves
K213073 · Thai Rubber Gloves Co., Ltd. · Dec 2021
Comfortpro
K212438 · Thai Rubber Industry Company Limited · Dec 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
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