510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K932953Substantially Equivalent

Dermal Gloves

George Glove Company, Inc., Englewood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932953 is the FDA 510(k) clearance record for DERMAL GLOVES, a class I device, cleared for George Glove Company, Inc. on under FDA product code LYU (Accessory, Surgical Apparel). FDA records list one 510(k) clearance for George Glove Company, Inc. As of , FDA records show no recalls naming K932953.

Clearance record

Decision date
Received
(372 days to decision)
Product code
LYU Accessory, Surgical Apparel
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
George Glove Company, Inc. 266 S. Dean St., Englewood NJ
510(k) summary
Statement
Third party review
No

Clearances, product code LYU

Trailing 12 months

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

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