Cleared Traditional

K994036 - PRE-POWDERED VINYL EXAM GLOVE, NON STERILE

K994036 is an FDA 510(k) clearance for PRE-POWDERED VINYL EXAM GLOVE, manufactured by Shanghai Champion 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 21-day FDA review.

K994036 · Shanghai Champion Plastic Products Co., Ltd. · General Hospital
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Dec 1999
Decision
21d
Days
Class 1
Risk

K994036 is an FDA 510(k) clearance for the PRE-POWDERED VINYL EXAM GLOVE, NON STERILE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Champion Plastic Products Co., Ltd. (Sparks, US). The FDA issued a Cleared decision on December 20, 1999 after a review of 21 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 Shanghai Champion Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K994036

510(k) Number K994036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1999
Decision Date December 20, 1999
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 205
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K994036.
SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
K993859 · Shanghai Glovmax Enterprise Co.,Ltd · Jan 2000
SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K993880 · Shanghai Glovmax Enterprise Co.,Ltd · Jan 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
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K992862 · Shijiazhuang Great Vision Plastic Products Co., LT · Nov 1999
DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES
K993049 · Shanghai Antares Industries, Inc. · Nov 1999