Custom Dressing Change Trays
FDA 510(k) K791738 · Sterile Design, Inc.
510(k) numberK791738
Submission
- Device name
- Custom Dressing Change Trays
- Applicant
- Sterile Design, Inc.
Mchenry, IL, US - Received
- August 30, 1979
- Decision date
- October 2, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMC – Patient Examination Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
Other 510(k)s with product code FMC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042618 | Laglove Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color)FMC · Traditional | La Glove (M) Sdn. Bhd. | 11/26/2004SE |
| K014134 | Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G)FMC · Traditional | Supergrade Healthcare Products Sdn. Bhd. | 01/22/2002SE |
| K992337 | Blossom Powder Free Latex Examination Gloves with Protein Content Labeling Claim 50 MCGM…FMC · Traditional | Mexpo Intl., Inc. | 08/17/1999SE |
| K932405 | Nitrile Rubber Examination Gloves (Powered)FMC · Traditional | Safeskin Corp. | 05/18/1994SE |
| K932404 | Nitrile Rubber Powder-Free Examination GloveFMC · Traditional | Safeskin Corp. | 05/18/1994SE |
| K923175 | Surgical Instrument Kit, DisposableFMC · Traditional | Ulti-Med Intl., Inc. | 06/17/1993SE |
| K920649 | CompasepFMC · Traditional | Wilde-USA, Inc. | 07/23/1992SE |
| K915376 | Glasion VarnishFMC · Traditional | Sci-Pharm Scientific Pharmaceutical, Inc. | 01/22/1992SE |
| K905127 | Latex Glove Application and Removal SystemFMC · Traditional | Success Builders Intl., Inc. | 01/30/1991SE |
| K905109 | Patient Examination Glove/HypoallergenicFMC · Traditional | Tactyl Technologies, Inc. | 11/21/1990SE |
More from Tactyl Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934688 | Sterile DesignLRO · Traditional | 03/16/1994SEKD |
| K841960 | Cardio Metrics Invasive Pressure MonitDRS · Traditional | 11/08/1985SE |
| K842356 | Custom Sterile Procedure Kits · Traditional | 03/21/1985SE |
| K841959 | Cardio Metric Custom Perfusion TubingDWE · Traditional | 10/19/1984SE |
| K842351 | Sterile Design-Custom Sterile IV KitFPA · Traditional | 10/15/1984SE |
| K841958 | Cardio Metrics Cardiotomy ReservoirJOD · Traditional | 10/15/1984SE |
| K834239 | Sdi C-Flex Sterile Light Handle · Traditional | 04/25/1984SE |
| K834237 | Graduated Guide Wire Bowl 8DQX · Traditional | 02/04/1984SE |
| K813437 | Pan SetFRG · Traditional | 12/31/1981SE |
Questions and answers
When was Custom Dressing Change Trays cleared by the FDA?
Custom Dressing Change Trays (K791738) received a 510(k) decision of Substantially Equivalent on October 2, 1979, 33 days after the submission was received.
What is the product code of K791738?
The FDA product code is FMC – Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.