Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
M.R.G. Industries Sdn. Bhd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
102 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991304 | HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, | M.R.G. Industries Sdn. Bhd. | 1999-06-23 | 68 | 0 |
| K991305 | HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES | M.R.G. Industries Sdn. Bhd. | 1999-06-21 | 66 | 0 |
| K981893 | HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES | M.R.G. Industries Sdn. Bhd. | 1998-06-22 | 24 | 0 |
| K941451 | MRG POWDER FREE LATEX EXAMINATION GLOVES | M.R.G. Industries Sdn. Bhd. | 1994-06-21 | 89 | 0 |
| K891374 | PATIENT EXAMINATION GLOVES (LATEX) | M.R.G. Industries Sdn. Bhd. | 1989-06-19 | 102 | 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