Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Glovco (M) Sdn. Bhd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
267 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051345 | COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION G | Glovco (M) Sdn. Bhd. | 2005-06-23 | 31 | 0 |
| K042898 | PANTHERA N POWDER FREE BLACK NITRILE GLOVES | Glovco (M) Sdn. Bhd. | 2005-01-18 | 90 | 0 |
| K013828 | GLOVCO EBONY | Glovco (M) Sdn. Bhd. | 2002-08-13 | 267 | 0 |
| K021730 | GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE) | Glovco (M) Sdn. Bhd. | 2002-07-05 | 42 | 0 |
| K021308 | GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES | Glovco (M) Sdn. Bhd. | 2002-05-14 | 19 | 0 |
| K994013 | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABEL | Glovco (M) Sdn. Bhd. | 2000-01-20 | 55 | 0 |
| K993752 | GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WIT | Glovco (M) Sdn. Bhd. | 1999-12-03 | 28 | 0 |
| K991554 | GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CO | Glovco (M) Sdn. Bhd. | 1999-07-09 | 67 | 0 |
| K991043 | LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN | Glovco (M) Sdn. Bhd. | 1999-05-04 | 36 | 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