510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063810Substantially Equivalent

Yulex Latex Powder-Free Exam Gloves

Yulex Corporation, Maricopa AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063810 is the FDA 510(k) clearance record for YULEX LATEX POWDER-FREE EXAM GLOVES, a class I device, cleared for Yulex Corporation on under FDA product code OIG (Powder-Free Guayle Rubber Examination Glove). FDA's definition for product code OIG reads: "A disposable patient examination glove made from guayule natural rubber latex. This alternative source of natural rubber latex (guayale) does not contain the same protein associated with allergic reactions to latex products from the hevea...". FDA records list one 510(k) clearance for Yulex Corporation. As of , FDA records show no recalls naming K063810.

Clearance record

Decision date
Received
(483 days to decision)
Product code
OIG Powder-Free Guayle Rubber Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Yulex Corporation 37860 W Smith-Enke Rd., Maricopa AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OIG

Trailing 12 months

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

FDA records show no clearances under product code OIG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OIG, 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