510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K994124Substantially Equivalent

Niprotect Powder-Free Nitrile Examination Gloves

Mapa Professional, Saltillo Coah, MX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994124 is the FDA 510(k) clearance record for NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES, a class I device, cleared for Mapa Professional 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 Mapa Professional. As of , FDA records show no recalls naming K994124.

Clearance record

Decision date
Received
(248 days to decision)
Product code
LZA Polymer Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Mapa Professional Carretera Saltillo-General, Saltillo Coah, MX
510(k) summary
Summary
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