510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801998Substantially Equivalent

Sterile Examination Glove #5121-5126

Pollak (Intl.).ltd, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801998 is the FDA 510(k) clearance record for STERILE EXAMINATION GLOVE #5121-5126, a class I device, cleared for Pollak (Intl.), Ltd. on under FDA product code FMC (Patient Examination Glove). FDA records list 31 510(k) clearances for Pollak (Intl.), Ltd., from to . As of , FDA records show no recalls naming K801998.

Clearance record

Decision date
Received
(20 days to decision)
Product code
FMC Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Pollak (Intl.), Ltd. 4221 Richmond Rd., NW, Walker MI
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