Cleared Traditional

K211620 - Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)

K211620 is an FDA 510(k) clearance for Biodegradable Powder Free Latex Examina..., manufactured by Shen Wei (Usa), Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K211620 · Shen Wei (Usa), Inc. · General Hospital
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Aug 2021
Decision
85d
Days
Class 1
Risk

K211620 is an FDA 510(k) clearance for the Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and G.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Shen Wei (Usa), Inc. (Union City, US). The FDA issued a Cleared decision on August 19, 2021 after a review of 85 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 Shen Wei (Usa), Inc. devices

FDA 510(k) Submission Details - K211620

510(k) Number K211620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2021
Decision Date August 19, 2021
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

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 633
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K211620.
Best Glove-Latex Powder Free Examination Glove
K210253 · Bestsafe Glove Co., Ltd. · Nov 2021
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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
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
Blue Latex Examination Powder Free Gloves
K192329 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Nov 2019