510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K122176Substantially Equivalent

Powdered Vinyl Examination Gloves

Shu Tong Xinghua Co., Ltd., Xinghua, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K122176 is the FDA 510(k) clearance record for POWDERED VINYL EXAMINATION GLOVES, a class I device, cleared for Shu Tong Xinghua Co., Ltd. on under FDA product code LYZ (Vinyl Patient Examination Glove). FDA's definition for product code LYZ reads: "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...". FDA records list 2 510(k) clearances for Shu Tong Xinghua Co., Ltd. As of , FDA records show no recalls naming K122176.

Clearance record

Decision date
Received
(627 days to decision)
Product code
LYZ Vinyl Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Shu Tong Xinghua Co., Ltd. West Of Xi Huan Rd., Xinghua, CN
510(k) summary
Statement
Third party review
No

Clearances, product code LYZ

Trailing 12 months
1 clearance under product code LYZ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LYZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260