Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Influx Pacific Sdn. Bhd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
253 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980511 | NITRILE EXAMINATION GLOVES - POWDER FREE | Influx Pacific Sdn. Bhd. | 1998-03-13 | 31 | 0 |
| K970216 | NITRILE EXAMINATION GLOVES-PRE POWDERED | Influx Pacific Sdn. Bhd. | 1997-09-26 | 253 | 0 |
| K930407 | POWDER-FREE LATEX EXAMINATION GLOVES | Influx Pacific Sdn. Bhd. | 1993-08-25 | 211 | 0 |
| K910895 | SURGICAL GLOVES | Influx Pacific Sdn. Bhd. | 1991-07-22 | 140 | 0 |
| K891668 | PATIENT EXAMINATION GLOVES (LATEX) | Influx Pacific Sdn. Bhd. | 1989-07-31 | 133 | 0 |
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