Atlas FDA

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

Alliance Rubber Products Sdn. Bhd. — Predicate Candidate Screening

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

66 daysmedian FDA review time
101 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K002701POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE Alliance Rubber Products Sdn. Bhd.2000-09-13140
K992870POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELINGAlliance Rubber Products Sdn. Bhd.1999-10-15500
K991981NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BAlliance Rubber Products Sdn. Bhd.1999-08-05520
K990486NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOAlliance Rubber Products Sdn. Bhd.1999-04-23660
K990485NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLAlliance Rubber Products Sdn. Bhd.1999-04-23660
K990427ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREEAlliance Rubber Products Sdn. Bhd.1999-04-23710
K990453NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLORAlliance Rubber Products Sdn. Bhd.1999-03-09250
K983146ARSOFTAlliance Rubber Products Sdn. Bhd.1998-12-07900
K980589AR SAFE NITRILE EXAMINATION GLOVESAlliance Rubber Products Sdn. Bhd.1998-04-14560
K972801ALLIANCE RUBBER, EC-GRIPAlliance Rubber Products Sdn. Bhd.1997-10-21850
K971183GOLD FINGERSAlliance Rubber Products Sdn. Bhd.1997-08-081300
K896673LATEX PATIENT EXAMINATION GLOVESAlliance Rubber Products Sdn. Bhd.1990-03-081010

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