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#
- 3012391162
- 3003807757
- 3017297225
- 3008392711
- 2135339
- 3008242042
- 3006517436
- 3010160527
- 3039386251
- 3006065092
- 3032327991
- 3008244559
- 1319639
- 3031233007
- 3010175283
- 3008770963
- 3011088743
- 3003403221
- 3014584671
- 1921846
- 3026263452
- 2320961
- 3010610950
- 1423537
- 3044466317
- 3000268902
- 3009655869
- 3013872035
- 3020188747
- 1038758
- 9680794
- 3013863160
- 3023339256
- 3031582449
- 3012979524
- 3019315696
- 3026844237
- 3042272797
- 3004681519
- 3013820501
- 1061124
- 3015277818
- 3011210302
- 3030626857
- 3010288357
- 3044777107
- 3038200636
- 3018101380
- 1025483
- 3031184338
- 3006210673
- 9616088
- 3007648359
- 3012535730
- 3007417776
- 3017231740
- 3016758972
- 3011238790
- 3021630959
- 3010155648
- 3031841433
- 3035786168
- 3007125968
- 9611024
- 3045076483
- 9710020
- 3013154850
- 3017396949
- 3017264244
- 3007327603
- 3041276890
- 3011556876
- 3006802076
- 3011191255
- 3015142802
- 3016450032
- 3019804885
- 3007360701
- 1720929
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 |
| K043063 | OXYBAND WOUND DRESSING | Oxyband Technologies, Inc. | 2005-03-24 |
| 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 |