510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K903746Substantially Equivalent

Comfit, Patient Examination Gloves

Wembley Rubber Products (M) Sdn Bhd, Kuala Lumpur, Malaysia, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903746 is the FDA 510(k) clearance record for COMFIT, PATIENT EXAMINATION GLOVES, a class I device, cleared for Wembley Rubber Products (M) Sdn Bhd on under FDA product code FMC (Patient Examination Glove). FDA records list 61 510(k) clearances for Wembley Rubber Products (M) Sdn Bhd, from to . As of , FDA records show no recalls naming K903746.

Clearance record

Decision date
Received
(23 days to decision)
Product code
FMC Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Wembley Rubber Products (M) Sdn Bhd 11th Floor, Menara Apera Ulg, Kuala Lumpur, Malaysia, MY
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260