510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011407Substantially Equivalent

Latex Powder-Free Examination Gloves Blue, Polymer Coated, Contains 50 Micrograms or Less of Total Water Extractable Pro

Sempermed USA, Inc., Palm Harbor FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011407 is the FDA 510(k) clearance record for LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO, a class I device, cleared for Sempermed USA, Inc. 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 2 510(k) clearances for Sempermed USA, Inc., from to . As of , FDA records show no recalls naming K011407.

Clearance record

Decision date
Received
(145 days to decision)
Product code
LYY Latex Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Sempermed USA, Inc. 30798 Us Hwy. 19n, Palm Harbor FL
510(k) summary
Summary
Third party review
No

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