510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211667Substantially Equivalent

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

Changzhou Universal Medical Equipment Co., Ltd., Changzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211667 is the FDA 510(k) clearance record for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile), a class I device, cleared for Changzhou Universal Medical Equipment Co., Ltd. on under FDA product code LAZ (N-Acetylprocainamide Control Materials). FDA records list 3 510(k) clearances for Changzhou Universal Medical Equipment Co., Ltd., from to . As of , FDA records show no recalls naming K211667.

Clearance record

Decision date
Received
(114 days to decision)
Product code
LAZ N-Acetylprocainamide Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Changzhou Universal Medical Equipment Co., Ltd. # 6, Xinxi Rd., Xinbei District, Changzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LAZ

Trailing 12 months

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

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