Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Multisafe Sdn. Bhd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
808 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161085 | Nitrile Patient Examination Powder Free Glove, Textured, Bla | Multisafe Sdn. Bhd. | 2018-07-05 | 808 | 0 |
| K062526 | BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE | Multisafe Sdn. Bhd. | 2007-04-13 | 228 | 0 |
| K062527 | BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | Multisafe Sdn. Bhd. | 2007-02-20 | 176 | 0 |
| K011293 | POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, | Multisafe Sdn. Bhd. | 2001-07-10 | 71 | 0 |
| K001497 | MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) | Multisafe Sdn. Bhd. | 2000-07-26 | 72 | 0 |
| K001619 | MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) | Multisafe Sdn. Bhd. | 2000-07-26 | 62 | 0 |
| K000999 | MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH | Multisafe Sdn. Bhd. | 2000-05-22 | 55 | 0 |
| K993811 | MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE | Multisafe Sdn. Bhd. | 2000-03-02 | 113 | 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