Cleared Traditional

K012711 - DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES

K012711 is an FDA 510(k) clearance for DISPOSABLE POWDER FREE VINYL PATIENT EX..., manufactured by Shijiazhuang Brilliance Plastic Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K012711 · Shijiazhuang Brilliance Plastic Co., Ltd. · General Hospital
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Sep 2001
Decision
35d
Days
Class 1
Risk

K012711 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Brilliance Plastic Co., Ltd. (North Billerica, US). The FDA issued a Cleared decision on September 18, 2001 after a review of 35 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.

FDA 510(k) Submission Details - K012711

510(k) Number K012711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date September 18, 2001
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

LYZ Device Classification - Class 1, General Controls

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 Peers - LYZ Vinyl Patient Examination Glove

All 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K012711.
ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
K012339 · Shanghai Antares Industries, Inc. · Oct 2001
ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
K012499 · Shanghai Antares Industries, Inc. · Oct 2001
DISPOSABLE POWDERED VINYL EXAMINATION GLOVES
K012710 · Shijiazhuang Brilliance Plastic Co., Ltd. · Oct 2001
STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K012282 · Cypress Medical Products, Ltd. · Aug 2001
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K011883 · Shijiazhuang Eversharp Plastic Products Co., Ltd. · Jul 2001
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K011884 · Shijiazhuang Eversharp Plastic Products Co., Ltd. · Jul 2001
K012711 · DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES
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