Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kl-Kepong Rubber Products Sdn. Bhd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243133 | Nitrile Powder Free Examination Gloves with Low Dermatitis P | Kl-Kepong Rubber Products Sdn. Bhd. | 2025-06-17 | 260 | 0 |
| K220118 | Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile | Kl-Kepong Rubber Products Sdn. Bhd. | 2022-05-12 | 118 | 0 |
| K023866 | POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIAT | Kl-Kepong Rubber Products Sdn. Bhd. | 2003-01-24 | 65 | 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