Compasep
FDA 510(k) K920649 · Wilde-USA, Inc.
510(k) numberK920649
Submission
- Device name
- Compasep
- Applicant
- Wilde-USA, Inc.
Chicago, IL, US - Received
- February 12, 1992
- Decision date
- July 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K903746 | Comfit, Patient Examination GlovesFMC · Traditional | Wembley Rubber Products (M) Sdn Bhd | 09/05/1990SE |
More from Wembley Rubber Products (M) Sdn Bhd
| 510(k) | Device | Decision |
|---|---|---|
| K913582 | Compatit RELM · Traditional | 06/24/1993SE |
| K915653 | KeramailEIH · Traditional | 04/08/1993SE |
| K913581 | Wilde Adhesive Bonding SystemKLE · Traditional | 02/26/1993SE |
| K923472 | CompacolorEBF · Traditional | 10/13/1992SE |
| K915250 | Wil-Pds & Wil-Pdi Casting AlloysEJH · Traditional | 04/21/1992SE |
| K913089 | Wilde Light Curing Composite Restorative ResinsEBF · Traditional | 04/21/1992SE |
| K912990 | ConverbaseEBI · Traditional | 03/25/1992SE |
| K920557 | Wil-O-Dont Orthodontic Material/Wil-O-LuxEBI · Traditional | 03/20/1992SE |
| K915654 | Keralloy-D CapsEJJ · Traditional | 03/02/1992SE |
| K912993 | Wilde Denture ResinsEBI · Traditional | 02/03/1992SE |
Questions and answers
When was Compasep cleared by the FDA?
Compasep (K920649) received a 510(k) decision of Substantially Equivalent on July 23, 1992, 162 days after the submission was received.
What is the product code of K920649?
The FDA product code is FMC – Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.