510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K183263Substantially Equivalent

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

Unipack Medical Corporation, Santa Fe Springs CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183263 is the FDA 510(k) clearance record for UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope, a class II device, cleared for Unipack Medical Corporation on under FDA product code PEM (Dental Barriers And Sleeves). FDA's definition for product code PEM reads: "Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients". FDA records list one 510(k) clearance for Unipack Medical Corporation. As of , FDA records show no recalls naming K183263.

Clearance record

Decision date
Received
(203 days to decision)
Product code
PEM Dental Barriers And Sleeves
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Unipack Medical Corporation 9830 Norwalk Blvd., Suite 100, Santa Fe Springs CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PEM

Trailing 12 months
2 clearances under product code PEM in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code PEM, 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 20262
October 20260