510(k) K254246
- Device
- LT Antibacterial Foam with Silver Dressing
- Applicant
- Zhejiang Longterm Medical Technology Co., Ltd.
- 510(k) number
- K254246
- Product code
- NAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-10
- Date received
- 2025-12-29
- Regulation
- 878.4020
- Classification name
- Dressing, Wound, Occlusive
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Claudia Zsang
- Address
- Shuangshan Rd. 277, Fuxi St. Deqing CN 313200 313200
FDA Registration Numbers#
- 3005030934
- 8010485
- 3017417635
- 3021630959
- 3010175283
- 3010131137
- 3045742729
- 3004122598
- 1319639
- 3015276780
- 1646434
- 3009882464
- 3015937050
- 3011248163
- 3015277818
- 9710603
- 3029875292
- 3009155880
- 3007360701
- 3014312726
- 3005841027
- 3011862887
- 3023141635
- 1644312
- 3010288357
- 3015140210
- 3003348807
- 2320762
- 3017390965
- 3010763707
- 3042261316
- 3011556876
- 1000317571
- 9617592
- 3019532551
- 3021035729
- 3010419931
- 3010595009
- 3044026004
- 3005619478
- 3008958609
- 3011707784
- 3002787468
- 3007648359
- 3014195785
- 3034531759
- 3012777736
- 3016901080
- 3012441818
- 3010610950
- 3004135030
- 3044150131
- 3032327991
- 3007187674
- 2951555
- 9618003
- 3045058049
- 1222274
- 2320961
- 3039435289
- 3008244559
- 3013154850
- 3009562494
- 3014368824
- 3016096140
- 3007966889
- 3005460813
- 3008076203
- 3014437893
- 3010339057
- 3033273018
- 3008392077
- 3008242042
- 3026844237
- 3015821396
- 3017231740
- 1649518
- 1061927
- 3003965134
- 1018120
Source Documents#
Other 510(k) Records For Product Code NAD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102403 | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL | Sam Medical Products | 2011-03-03 |
| K091133 | APLION TOPICAL CARE SYSTEM | Aplion Medical,Llc | 2009-05-20 |
| K072560 | ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) | Teikoku Pharma USA, Inc. | 2008-06-17 |
| K080524 | CENTURION SORBAVIEW OTC | Tri-State Hospital Supply Corp. | 2008-04-23 |
| K060046 | DERMASTREAM | Enzysurge , Ltd. | 2006-02-27 |
| K020781 | WET CHAMBER | Kinetic Concepts, Inc. | 2002-05-06 |
| K990530 | KERLIX MD ANTIMICROBIAL GAUZE DRESSING | The Kendall Company, L.P. | 2000-01-31 |
| K990861 | WOUND DRESSING/ABD PAD, MODEL #10810 | Hospital Specialty Co. | 1999-04-12 |
| K964534 | OTOSILK OTOLOGICAL GRAFT DRESSING | Boston Medical Products, Inc. | 1997-04-09 |
| K960815 | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL | Dumex Medical Surgical Products, Ltd. | 1996-04-29 |
| K955863 | ALLDRESS MULTI LAYERED WOUND DRESSING | Molnlycke/Scott Health Care | 1996-03-13 |
| K952203 | OTOSILK | Boston Medical Products, Inc. | 1995-07-31 |
| K930697 | MEDLINE STERILE GAUZE SPONGES | Medline Industries, Inc. | 1993-06-24 |
| K912022 | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1991-08-02 |
| K905519 | MONTROSE DRESSING APPLICATORS | Olemunda Pty , Ltd. | 1991-03-06 |