Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Allmed Medical (Hubei) Protective Products Co., Ltd. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221637 | Surgical Gown (Sterile); Surgical Gown (Non-sterile) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022-09-29 | 115 | 0 |
| K221027 | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022-08-12 | 128 | 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