510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112988Substantially Equivalent

Powder Free Latex Patient Exam Glove with Protein Labeling Claim (50 Micrograms per Dm Squared or Less of Water Soluble

Northstar Healthcare Holdings, Mc Henry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112988 is the FDA 510(k) clearance record for POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE, a class I device, cleared for Northstar Healthcare Holdings Limited on under FDA product code LYY (Latex Patient Examination Glove). FDA's definition for product code LYY reads: "A latex patient examination glove is a disposable device made of natural rubber latex 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 10 510(k) clearances for Northstar Healthcare Holdings Limited, from to . As of , FDA records show no recalls naming K112988.

Clearance record

Decision date
Received
(34 days to decision)
Product code
LYY Latex Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Northstar Healthcare Holdings Limited 1202 S. Rte. 31, Mc Henry IL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code LYY

Trailing 12 months

FDA records hold no clearances under product code LYY in the trailing twelve months.

FDA records show no clearances under product code LYY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LYY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260