Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Sj Medical Products (M) Sdn Bhd · Predicate Candidate Screening

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

52 daysmedian FDA review time
306 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K971666SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVESSj Medical Products (M) Sdn Bhd1997-07-03580
K971665SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVESSj Medical Products (M) Sdn Bhd1997-06-27520
K971403SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVESj Medical Products (M) Sdn Bhd1997-05-29440
K941754POWDER FREE LATEX EXMINATION GLOVESSj Medical Products (M) Sdn Bhd1994-05-09310
K932332PATIENT EXAMINATION GLOVE - POWDEREDSj Medical Products (M) Sdn Bhd1994-03-153060

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