Atlas FDA

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

Ampri Rubberware Industries Sdn Bhd — Predicate Candidate Screening

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

157 daysmedian FDA review time
244 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K990677ABSOGEL CHEMOTHERAPHY GLOVESAmpri Rubberware Industries Sdn Bhd1999-11-012440
K990812POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAmpri Rubberware Industries Sdn Bhd1999-05-04540
K954002AMPRIAmpri Rubberware Industries Sdn Bhd1996-01-291570
K952833AMPRIAmpri Rubberware Industries Sdn Bhd1995-09-05770
K945948ABSOGEL STERILE POWDER-FREE SURGICAL GLOVESAmpri Rubberware Industries Sdn Bhd1995-07-312370
K946056ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE)Ampri Rubberware Industries Sdn Bhd1995-07-202260
K892176CORRECT TOUCH SURGEONS GLOVESAmpri Rubberware Industries Sdn Bhd1989-09-061540
K892175CORRECT TOUCH EXAMINATION GLOVES (LATEX)Ampri Rubberware Industries Sdn Bhd1989-08-251420

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