510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K932404Substantially Equivalent

Nitrile Rubber Powder-Free Examination Glove

Safeskin Corp., Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932404 is the FDA 510(k) clearance record for NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE, a class I device, cleared for Safeskin Corp. on under FDA product code FMC (Patient Examination Glove). FDA records list 24 510(k) clearances for Safeskin Corp., from to . As of , FDA records show no recalls naming K932404.

Clearance record

Decision date
Received
(370 days to decision)
Product code
FMC Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Safeskin Corp. Crocker Center, Boca Raton FL
510(k) summary
Statement
Third party review
No

Clearances, product code FMC

Trailing 12 months

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

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