Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Gx Corporation Sdn Bhd — Predicate Candidate Screening

18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

95 daysmedian FDA review time
199 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200915Powder Free White Sterilized Polyisoprene Surgical Gloves-TeGx Corporation Sdn Bhd2021-07-094590
K183354Powder Free Blue Nitrile Examination Gloves Tested for use wGx Corporation Sdn Bhd2019-06-201990
K111328POWDER FREE NITRILE EXAMINATION GLOVESGx Corporation Sdn Bhd2011-07-15650
K102074POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH Gx Corporation Sdn Bhd2010-11-02990
K101828POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOGx Corporation Sdn Bhd2010-10-04950
K091851STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTEDGx Corporation Sdn Bhd2009-12-281890
K092072POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUEGx Corporation Sdn Bhd2009-11-041190
K091643POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WGx Corporation Sdn Bhd2009-11-021510
K092200POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTGx Corporation Sdn Bhd2009-09-16560
K090412POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,Gx Corporation Sdn Bhd2009-06-011030
K091151POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GRGx Corporation Sdn Bhd2009-06-01420
K083717POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, Gx Corporation Sdn Bhd2009-01-30460
K081315POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CGx Corporation Sdn Bhd2008-08-11940
K080937POWDER FREE NITRILE EXAMINATION GLOVE, ORANGEGx Corporation Sdn Bhd2008-05-23510
K080066VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PIGx Corporation Sdn Bhd2008-03-05550
K071119POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CGx Corporation Sdn Bhd2007-07-24950
K070097POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, Gx Corporation Sdn Bhd2007-03-23720
K070096POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BGx Corporation Sdn Bhd2007-03-14630

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda