Cleared Traditional

K992156 - SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES

K992156 is an FDA 510(k) clearance for SYNSATION STERILE POWDER FREE, manufactured by Ansell Perry. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K992156 · Ansell Perry · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
124d
Days
Class 1
Risk

K992156 is an FDA 510(k) clearance for the SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Ansell Perry (Massillon, US). The FDA issued a Cleared decision on October 27, 1999 after a review of 124 days - within the typical 510(k) review window.

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 Ansell Perry devices

FDA 510(k) Submission Details - K992156

510(k) Number K992156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1999
Decision Date October 27, 1999
Days to Decision 124 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 129d · This submission: 124d
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 674
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K992156.
DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES
K993049 · Shanghai Antares Industries, Inc. · 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
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
K993231 · Shinemound Enterprise, Inc. · Oct 1999
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
K993240 · Shinemound Enterprise, Inc. · Oct 1999
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992555 · Shijiazhuang Great Vision Plastic Products Co., LT · Oct 1999