510(k) K141324
- Device
- HONGYU DISPOSABLE SURGICAL DRAPES
- Applicant
- WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD
- 510(k) number
- K141324
- Product code
- KKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-14
- Date received
- 2014-05-20
- Regulation
- 878.4370
- Classification name
- Drape, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Diana Hong
- Address
- P.O. Box 120-119 Shanghai CN 200120 200120
FDA Registration Numbers#
- 3045816907
- 3013600605
- 1000563940
- 9616088
- 3031841433
- 3011063460
- 3013443304
- 9613558
- 3006540014
- 1066741
- 8043817
- 1018470
- 1037577
- 3007082891
- 3005748481
- 3006891803
- 3007487007
- 3016096096
- 3010432890
- 3013410562
- 2246552
- 3005012805
- 2183744
- 3011500469
- 1043549
- 3015612252
- 3035642068
- 3011140825
- 3013557562
- 3016761372
- 3007886583
- 2320762
- 1054241
- 9680222
- 3005997949
- 3001650535
- 3030446844
- 3008489813
- 3010041511
- 3014325891
- 3015173212
- 3020331900
- 3006897899
- 3004122598
- 1423537
- 3010885402
- 3005595283
- 1043644
- 2523676
- 3005675811
- 3015276780
- 9611024
- 3017820152
- 3045817901
- 3015859709
- 8030607
- 3011547453
- 1055236
- 1928237
- 1123137
- 3006538822
- 1721676
- 3001124136
- 3001003398
- 1417592
- 3011390076
- 9710018
- 3010493171
- 3011137372
- 3011237770
- 1060680
- 3004111573
- 1043214
- 3006973666
- 3011106828
- 9615551
- 1030451
- 3015153469
- 3008363989
- 3001675293
Source Documents#
Other 510(k) Records For Product Code KKX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230645 | BeneHold™ Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical , Ltd. | 2023-10-25 |
| K222578 | 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | 3M Company | 2023-05-18 |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobial | Avery Dennison Belgie Bvba | 2021-07-30 |
| K200238 | ControlRad Sterile Cover | Controlrad, Inc. | 2020-04-26 |
| K163556 | MediClear PreOp | Covalontechnologies, Inc. | 2017-09-14 |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | Foshan Nanhai Plus Medical Co, Ltd. | 2015-06-24 |
| K140195 | SURGICAL DRAPE | Griffith-Lucas, LLC | 2014-09-10 |
| K140330 | 3M STERI-DRAPE FABRIC SURGICAL DRAPES | 3M Healthcare | 2014-08-18 |
| K141438 | WHITNEY MEDICAL SOLUTIONS ESHIELD | Whitney Medical Solutions | 2014-08-14 |
| K140250 | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE | 3M Healthcare | 2014-07-25 |
| K140064 | SURGISLEEVE WOUND PROTECTOR | Covidien | 2014-03-12 |
| K131571 | AVD RIGHT RADIAL DRAPE | Advanced Vascular Dynamics | 2014-01-31 |
| K130404 | TIBURON SURGICAL DRAPE | Cardinal Health200, LLC | 2013-07-05 |
| K121436 | DAS MEDICAL EQUIPMENT DRAPES | Das Medical, LLC | 2013-06-06 |
| K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | Exact Medical Manufacturing, Inc. | 2013-02-14 |
Legacy Summary#
summary
FDA Review#
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