510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K081971Substantially Equivalent

Bioclean Chemo Ultimate Powder Free Polychloroprene Examination Gloves

Nitritex (M) Sdn. Bhd., Kuala Langat, Selangor De, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081971 is the FDA 510(k) clearance record for BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES, a class I device, cleared for Nitritex (M) 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 3 510(k) clearances for Nitritex (M) Sdn. Bhd., from to . As of , FDA records show no recalls naming K081971.

Clearance record

Decision date
Received
(166 days to decision)
Product code
LZC Medical Glove, Specialty
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Nitritex (M) Sdn. Bhd. Kebun Baru, Jln Masjid, Kuala Langat, Selangor De, MY
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