Cloth-Hypoallergenic
FDA 510(k) K840947 · Gainor Medical
510(k) numberK840947
Submission
- Device name
- Cloth-Hypoallergenic
- Applicant
- Gainor Medical
- Received
- March 5, 1984
- Decision date
- August 17, 1984
- 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 |
|---|---|---|
| K850100 | Blood LancetFMK · Traditional | 01/29/1987SE |
| K850150 | Ulster Scientific, Inc. Autolet Lancets/Gainor MedFMK · Traditional | 02/21/1985SE |
| K844306 | Gainor Medical SyringeFMF · Traditional | 11/30/1984SE |
| K844305 | Gainor Medical Flowmax NeedlesFMI · Traditional | 11/30/1984SE |
| K840951 | First Aid BandageKGX · Traditional | 10/31/1984SE |
| K840950 | Zinc Oxide TapeKGX · Traditional | 10/31/1984SE |
| K840945 | Skin ClosureFPX · Traditional | 10/31/1984SE |
| K840949 | Clear Plastic-HypoallergenicKGX · Traditional | 08/17/1984SE |
| K840946 | Microporous HypoallergenicKGW · Traditional | 08/17/1984SE |
| K840948 | Clear Porous Plastic-HypoallergenicGKX · Traditional | 08/14/1984SE |
Questions and answers
When was Cloth-Hypoallergenic cleared by the FDA?
Cloth-Hypoallergenic (K840947) received a 510(k) decision of Substantially Equivalent on August 17, 1984, 165 days after the submission was received.
What is the product code of K840947?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.