Cleared Traditional

K992797 - SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES

K992797 is an FDA 510(k) clearance for SYNTHETIC POWDERED VINYL PATIENT EXAMIN..., manufactured by Shijiazhuang Hongxiang Plastics 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 78-day FDA review.

K992797 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
78d
Days
Class 1
Risk

K992797 is an FDA 510(k) clearance for the SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Hongxiang Plastics Products Co; , Ltd. (Chino, US). The FDA issued a Cleared decision on November 5, 1999 after a review of 78 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 Shijiazhuang Hongxiang Plastics Products Co; , Ltd. devices

FDA 510(k) Submission Details - K992797

510(k) Number K992797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1999
Decision Date November 05, 1999
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
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 K992797.
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
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
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
K993231 · Shinemound Enterprise, Inc. · Oct 1999