Cleared Traditional

K954381 - SHANGHAI POSEDON PLASTIC PRODUCTS VINYL EXAM GLOVES

K954381 is an FDA 510(k) clearance for SHANGHAI POSEDON PLASTIC PRODUCTS VINYL..., manufactured by Shanghai Poseidon Plastic Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K954381 · Shanghai Poseidon Plastic Products Co., Ltd. · General Hospital
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Dec 1995
Decision
83d
Days
Class 1
Risk

K954381 is an FDA 510(k) clearance for the SHANGHAI POSEDON PLASTIC PRODUCTS VINYL EXAM GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Poseidon Plastic Products Co., Ltd. (Mchenry, US). The FDA issued a Cleared decision on December 11, 1995 after a review of 83 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 - K954381

510(k) Number K954381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1995
Decision Date December 11, 1995
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K954381.
SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES
K960746 · Sunmax Enterprise Shanghai Co. , Ltd. · Jun 1996
ARISTA VINYL EXAMINATION GLOVES
K954153 · Arista Latindo Industrial Ltd. P.T · Jan 1996
DISPOSABLE POWDER FREE VINYL SYNTHETIC GLOVES
K955091 · Safehealth Medical Supply Corp. · Dec 1995
MORE CHAIN POWDER FREE VINYL EXAMINATION GLOVES
K951007 · Allerderm Laboratories, Inc. · Jul 1995
VINYL PATIENT EXAMINATION GLOVES
K941809 · Cheer & Merit Co., Ltd. · Jul 1995
TRIFLEX STERILE SYNTHETIC EXAMINATION GLOVES
K952786 · Baxter Healthcare Corp · Jul 1995
K954381 · SHANGHAI POSEDON PLASTIC PRODUCTS VINYL EXAM GLOVES
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