Cleared Traditional

K992979 - SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW

K992979 is an FDA 510(k) clearance for SHANGHAI POSEIDON POWDER-FREE SYNTHETIC..., 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 159-day FDA review.

K992979 · Shanghai Poseidon Plastic Products Co., Ltd. · General Hospital
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Feb 2000
Decision
159d
Days
Class 1
Risk

K992979 is an FDA 510(k) clearance for the SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Poseidon Plastic Products Co., Ltd. (Jinshan Shanghai, CN). The FDA issued a Cleared decision on February 9, 2000 after a review of 159 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Shanghai Poseidon Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K992979

510(k) Number K992979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1999
Decision Date February 09, 2000
Days to Decision 159 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 129d · This submission: 159d
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 141
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K992979.
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
K003091 · Medline Industries, Inc. · Oct 2000
VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR
K002745 · Arista Latindo Industrial Ltd. P.T · Oct 2000
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR
K002746 · Arista Latindo Industrial Ltd. P.T · Oct 2000
SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
K993664 · Top Glove Sdn. Bhd. · Jan 2000
SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
K993680 · Top Glove Sdn. Bhd. · Dec 1999
SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
K992156 · Ansell Perry · Oct 1999