Tricot Adhesive Bandage
FDA 510(k) K852462 · American White Cross, Inc.
510(k) numberK852462
Submission
- Device name
- Tricot Adhesive Bandage
- Applicant
- American White Cross, Inc.
Stamford, CT, US - Received
- June 10, 1985
- Decision date
- July 26, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KGX – Tape And Bandage, Adhesive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5240
- Specialty
- General Hospital
Other 510(k)s with product code KGX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001240 | Seragard Injection PatchKGX · Traditional | Platinum Services, Inc. | 06/21/2000SE |
| K983368 | Care Band Antibacterial BandagesKGX · Traditional | Aso Corp. | 02/17/1999SE |
| K972914 | Syvek PatchKGX · Traditional | Marine Polymer Technologies, Inc. | 12/22/1997SE |
| K943314 | Adhesive Bandages with OTC DrugKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 01/17/1996SE |
| K952606 | Targett PatchKGX · Traditional | Cutting Edge Technologies, Inc. | 12/21/1995SE |
| K954007 | ParallelKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 11/22/1995SE |
| K944587 | Dermiview Hypoallergenic Clear TapeKGX · Traditional | Johnson & Johnson Medical, Inc. | 10/30/1995SE |
| K944588 | Sterile Plastic DressingKGX · Traditional | Smith & Nephew, Inc. | 11/07/1994SE |
| K941788 | Band-Aid Brand Adhesive Bandages, Sport StripKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 10/03/1994SE |
| K940536 | Band-Aid(Tm) Brand Adhesive BandageKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 10/03/1994SE |
More from Johnson & Johnson Consumer Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964614 | Ultrafera Wound DressingKMF · Traditional | 02/06/1997SE |
| K962400 | Air Max External Nasal Dilator StripLWF · Traditional | 09/09/1996SE |
| K894802 | Awc Butterfly Wound ClosuresFPX · Traditional | 01/31/1990SE |
| K854809 | White Cross Sterile Pad 4IN. X 4IN. · Traditional | 01/13/1986SE |
| K853558 | Dosimetric Release/Radiation Steriliz. Absorb Gauz · Traditional | 09/05/1985SE |
| K853334 | Non-Adhera Adhesive Pad 3X4NAD · Traditional | 08/21/1985SE |
| K852412 | Non-Adherent PadEFQ · Traditional | 07/29/1985SE |
| K852408 | Extra Large Adhesive StripsKGX · Traditional | 07/29/1985SE |
| K850595 | 3 X 4 Non-Adherent Pad · Traditional | 03/11/1985SE |
Questions and answers
When was Tricot Adhesive Bandage cleared by the FDA?
Tricot Adhesive Bandage (K852462) received a 510(k) decision of Substantially Equivalent on July 26, 1985, 46 days after the submission was received.
What is the product code of K852462?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.