510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K213058Substantially Equivalent

O'Star Nitrile Examination Gloves Powder Free

Star Investment and Trade Joint Stock Company, Bac Ninh, VN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213058 is the FDA 510(k) clearance record for O'Star Nitrile Examination Gloves Powder Free, a class I device, cleared for Star Investment and Trade Joint Stock Company 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 Star Investment and Trade Joint Stock Company. As of , FDA records show no recalls naming K213058.

Clearance record

Decision date
Received
(139 days to decision)
Product code
LZA Polymer Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Star Investment and Trade Joint Stock Company Khac Niem Industrial Cluster, Khac Niem Ward, Bac Ninh, VN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZA

Trailing 12 months
15 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 20260