First Aid Kit Without Drug
General, Plastic Surgery · 21 CFR 878.4014
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
5 adverse event reports on file
- PRIVATE LABELJul 9, 2026MalfunctionMedline Industries, Lp1417592-2026-04920
- EQUATE ANTIBACTERIAL BANDAGESFeb 5, 2025OtherTotal Resources International Inc.MW5165650
- FIRST AID KIT, CURAD, BAG, 15 CTSep 27, 2022InjuryMedline Industries Lp1417592-2022-00180
- ZIPSTITCH LACERATION KITApr 11, 2019InjuryZipline Medical3009673389-2019-00002
- FIRST AID KIT WITHOUT DRUGAug 15, 2018InjuryMedline Industries Inc.1417592-2018-00076
Event type breakdown
Registered firms
240 firms currently registered for this product code
L Well Medtech Solutions Sdn. Bhd.
Nibong Tebal Pulau Pinang, MY
Franz Kalff Gmbh
Euskirchen North Rhine-Westphalia, DE
Jiangsu Goju Identification Technology Co., Ltd.
YANCHENG CITY Jiangsu, CN
Total Resources Int'l.
Walnut, CA, US
M-pak, Inc.
Aledo, TX, US
Ningbo Jenius Polymer Sci-tech Co., Ltd
YinZhou District, Ningbo Zhejiang, CN
Zhejiang Hongyu Medical Commodity Co., Ltd.
YIWU Zhejiang, CN
Planet Holdings Limited
Hong Kong, HK
Allwin First Aid Supplies Taizhou Co., Ltd
Taizhou Jiangsu, CN
Aspire Group Na Ltd
Markham Ontario, CA
Ningbo Giftyland Co., Limited
Ningbo Zhejiang, CN
Zhejiang Kang Li Di Medical Articles Co., Ltd.
YUEQING CITY Zhejiang, CN
Anji Hengfeng Sanitary Material Co., Ltd.
Anji Zhejiang, CN
Planet(shanghai) International Co.,ltd
shanghai, CN
Changzhou Amt Healthcare Co., Ltd.
Changzhou Jiangsu, CN
Zhejiang Changdi Medical Co., Ltd.
JINHUA Zhejiang, CN
Uline, Inc.
Pleasant Prairie, WI, US
Lifeline First Aid Llc
Lake Oswego, OR, US
Sei Medical S.a. De C.v.
Juarez Chihuahua, MX
Yancheng Trancom First Aid Supplies Industrial Co., Ltd
Yangcheng Jiangsu, CN
Poolweb Llc
Augusta, ME, US
Jiangsu Yizheng Carepro Medical Instruments Co., Ltd.
Yizheng Jiangsu, CN
Dongyang City Yonoel Outdoor Products Co.,ltd
Dongyang Zhejiang, CN
Anqing Kangmingna Packaging Co.,ltd
Anqing Anhui, CN
Pujiang Jianyu Sanitary Products Company Ltd.
Jinhua Zhejiang, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.