Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
329 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K214088 | Disposable Surgical Gown | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2022-04-12 | 105 | 0 |
| K220133 | Sterilization Wraps | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2022-03-10 | 51 | 0 |
| K213029 | Nitrile Examination Gloves (Powder free, Blue) | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2021-12-14 | 84 | 0 |
| K212807 | Surgical Masks | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2021-12-03 | 91 | 0 |
| K141324 | HONGYU DISPOSABLE SURGICAL DRAPES | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2015-04-14 | 329 | 0 |
| K120192 | DISPOSABLE SURGICAL GOWNS | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2012-10-16 | 267 | 1 |
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