Cleared Traditional

K993049 - DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES

K993049 is an FDA 510(k) clearance for DISPOSABLE PVC POWDERED SYNTHETIC EXAMI..., manufactured by Shanghai Antares Industries, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K993049 · Shanghai Antares Industries, Inc. · General Hospital
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Nov 1999
Decision
70d
Days
Class 1
Risk

K993049 is an FDA 510(k) clearance for the DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Antares Industries, Inc. (Songjiang Shanghai, CN). The FDA issued a Cleared decision on November 19, 1999 after a review of 70 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 Antares Industries, Inc. devices

FDA 510(k) Submission Details - K993049

510(k) Number K993049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1999
Decision Date November 19, 1999
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
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 K993049.
PRE-POWDERED VINYL EXAM GLOVE, NON STERILE
K994036 · Shanghai Champion Plastic Products Co., Ltd. · Dec 1999
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
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992797 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · Nov 1999
PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
K983613 · Shanghai Jiatai Plastic Products Co., Ltd. · Oct 1999
SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
K992156 · Ansell Perry · Oct 1999