510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K014134Substantially Equivalent

Powder-Free Latex Exam Gloves with Protein Labeling (<50Ug/g)

Supergrade Healthcare Products Sdn. Bhd., Sparks NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014134 is the FDA 510(k) clearance record for POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G), a class I device, cleared for Supergrade Healthcare Products Sdn. Bhd. on under FDA product code FMC (Patient Examination Glove). FDA records list 3 510(k) clearances for Supergrade Healthcare Products Sdn. Bhd., from to . As of , FDA records show no recalls naming K014134.

Clearance record

Decision date
Received
(36 days to decision)
Product code
FMC Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Supergrade Healthcare Products Sdn. Bhd. 198 Ave. De La D'Emerald, Sparks NV
510(k) summary
Summary
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