Weihai Hongyu Nonwoven Fabric Products Co.,Ltd
Weihai Shandong, CN
Weihai Hongyu Nonwoven Fabric Products Co.,Ltd appears in FDA device records in Weihai Shandong, CN. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Weihai Hongyu Nonwoven Fabric Products Co.,Ltd between 2012 and 2022. The busiest year on record is 2021, with 2. The most recent is 2022, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2015 | 1 |
| 2021 | 2 |
| 2022 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K214088 | Disposable Surgical Gown | FYA | Substantially Equivalent | |
| K220133 | Sterilization Wraps | FRG | Substantially Equivalent | |
| K213029 | Nitrile Examination Gloves (Powder free, Blue) | LZA | Substantially Equivalent | |
| K212807 | Surgical Masks | FXX | Substantially Equivalent | |
| K141324 | HONGYU DISPOSABLE SURGICAL DRAPES | KKX | Substantially Equivalent | |
| K120192 | DISPOSABLE SURGICAL GOWNS | FYA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008489813 | 3008489813 | Weihai Hongyu Nonwoven Fabric Products Co.,Ltd | No.19-8, Weihai Shandong 264205 CN | 2026 | and 27 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- FNYBasin, Emesis
- KMEBedding, Disposable, Medical
- GESBlade, Scalpel
- GECBrush, Scrub, Operating-Room
- FYFCap, Surgical
- HXDClamp
- HFWClamp, Umbilical
- KYWContainer, Liquid Medication, Graduated
- FMWCover, Mattress (Medical Purposes)
- FXPCover, Shoe, Operating-Room
- EXJDevice, Incontinence, Urosheath Type, Sterile
- KKXDrape, Surgical, Antimicrobial
- FYEDress, Surgical
- HTDForceps
- EYQGarment, Protective, For Incontinence
- NABGauze / Sponge,Nonresorbable For External Use
- GDYGauze/Sponge, Internal, X-Ray Detectable
- FYAGown, Surgical
- HRQHemostat
- KDCInstrument, Surgical, Disposable
- IALIodine (Tincture)
- FXXMask, Surgical
- OEANon-Surgical Gown
- FWZOperating Room Accessories Table Tray
- HRPPen, Marking, Surgical
- LZAPolymer Patient Examination Glove
- MSHRespirator, Surgical
- GDXScalpel, One-Piece
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- OJUSkin Prep Tray
- KYZSyringe, Irrigating (Non Dental)
- KGXTape And Bandage, Adhesive
- LRPTray, Surgical
- FSMTray, Surgical, Instrument
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain