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
K111134Substantially Equivalent

Non-Sterile, Powder-Free Nitrile Examination Glove, Blue, Tested for Use with Chemotherapy Drugs

Siem Aempemed Corp., Ltd., Clearwater FL / Abbreviated, Substantially Equivalent

K111134 is the FDA 510(k) clearance record for NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, a class I device, cleared for Siem Aempemed Corp., Ltd. on under FDA product code LZA (Polymer Patient Examination Glove). FDA's definition for product code LZA reads: "A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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...". FDA records list one 510(k) clearance for Siem Aempemed Corp., Ltd. As of , FDA records show no recalls naming K111134.

Clearance record

Decision date
Received
(279 days to decision)
Product code
LZA Polymer Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Siem Aempemed Corp., Ltd. 13900 49th St., Clearwater FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZA

Trailing 12 months
16 clearances under product code LZA in the twelve months to October 2026, June 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code LZA, trailing twelve months
MonthClearances
November 20251
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20265
July 20262
August 20261
September 20264
October 20261