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#
- 3016607092
- 3007143236
- 3013557562
- 9611024
- 3005369776
- 3006437555
- 3018781093
- 9680284
- 3011140825
- 3006723155
- 1061124
- 1066741
- 1060680
- 9710018
- 3009888344
- 3013421458
- 3014325891
- 3020331900
- 3004122598
- 3005012805
- 3012494290
- 3011106828
- 3010157088
- 3011063460
- 2032841
- 1527607
- 3001003398
- 3009185973
- 1034084
- 3007829657
- 1065597
- 1319639
- 2427500
- 1032347
- 3011390076
- 3006538822
- 3012627460
- 3004519921
- 3027977504
- 3013820501
- 3013443304
- 3028006458
- 3013497020
- 9616088
- 1721686
- 3004133257
- 3012421607
- 3003495693
- 3010305275
- 3021274073
- 8030607
- 3014421917
- 3011237770
- 1123010
- 3016761372
- 1058584
- 1423395
- 9616876
- 3013283620
- 9615551
- 9680646
- 3016555232
- 3014663814
- 3015531959
- 3008363989
- 1037577
- 1420054
- 3009719225
- 3011137372
- 3044026004
- 3012026312
- 3015224777
- 3013298431
- 1043214
- 1423537
- 3007082891
- 3015709932
- 3015895145
- 3004361903
- 3004713352
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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