Medical Device
Manufacturing
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K102189Substantially Equivalent

Powder Free Nitrle Examination Gloves with Chemotherapy Labeling Claim

Latexx Manufacturing Sdn.Bhd., Wheat Ridge CO / Traditional, Substantially Equivalent

K102189 is the FDA 510(k) clearance record for POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM, a class I device, cleared for Latexx Manufacturing Sdn.Bhd. on under FDA product code LZC (Medical Glove, Specialty). FDA's definition for product code LZC reads: "A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition...". FDA records list 10 510(k) clearances for Latexx Manufacturing Sdn.Bhd., from to . As of , FDA records show no recalls naming K102189.

Clearance record

Decision date
Received
(590 days to decision)
Product code
LZC Medical Glove, Specialty
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Latexx Manufacturing Sdn.Bhd. 11925 W 1-70 Frontage Rd. N., Wheat Ridge CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZC

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