510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K922968Substantially Equivalent

Vinyl Exam Gloves

Normandin Pacific Holdings Corp., Lomita CA / Traditional, Substantially Equivalent

K922968 is the FDA 510(k) clearance record for VINYL EXAM GLOVES, a class I device, cleared for Normandin Pacific Holdings Corp. 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 one 510(k) clearance for Normandin Pacific Holdings Corp. As of , FDA records show no recalls naming K922968.

Clearance record

Decision date
Received
(222 days to decision)
Product code
LYZ Vinyl Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Normandin Pacific Holdings Corp. 25834 Cypress Ave., Lomita CA
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