Cleared Traditional

Single-use medical poly (vinyl chloride) examination glove (K201504) - FDA 510(k) Clearance

Class I General Hospital device.

K201504 · Anhui Bytech Medical Supplies Co., Ltd. · General Hospital
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May 2021
Decision
339d
Days
Class 1
Risk

K201504 is an FDA 510(k) clearance for the Single-use medical poly (vinyl chloride) examination glove. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Anhui Bytech Medical Supplies Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on May 10, 2021 after a review of 339 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 Anhui Bytech Medical Supplies Co., Ltd. devices

Submission Details

510(k) Number K201504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2020
Decision Date May 10, 2021
Days to Decision 339 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
210d slower than avg
Panel avg: 129d · This submission: 339d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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

Shanghai Sungo Management Consultanting Co., Ltd.
Ivy Wang

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 - LYZ Vinyl Patient Examination Glove

All 83
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K201504.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K210774 · Shandong Jieshi Medical Products Co., Ltd. · May 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K210780 · Shandong Shangwei Medical Products Co., Ltd. · May 2021
Powder Free Vinyl Patient Examination Gloves
K210799 · Yunnan Huazhiyuan Medical Technology Co., Ltd. · May 2021
Vinyl Examination Gloves(Yellow)
K203666 · Lutai Medical Technology Co., Ltd. · Mar 2021
Disposable Vinyl Examination Gloves
K203439 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Feb 2021
Vinyl Examination Gloves (Yellow)
K203702 · Xinying Trading Co., Ltd. · Feb 2021