Isolyser Orex Surgeon's Caps, Hoods, Bouffant Caps
FDA 510(k) K942200 · Thantex Specialties, Inc.
510(k) numberK942200
Submission
- Device name
- Isolyser Orex Surgeon's Caps, Hoods, Bouffant Caps
- Applicant
- Thantex Specialties, Inc.
Norcross, GA, US - Received
- May 5, 1994
- Decision date
- August 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LYU – Accessory, Surgical Apparel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LYU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011755 | Stryker T4 Hytrel (R) TogasLYU · Special | Stryker Corp. | 06/22/2001SE |
| K965237 | Nurses Bouffant CapLYU · Traditional | Copioumed Intl., Inc. | 08/27/1997SE |
| K970988 | Far-East Bouffant CapsLYU · Traditional | Far East Science & Technology Development Co.… | 07/10/1997SE |
| K964364 | Disposable ApronLYU · Traditional | Instrument Makar, Inc. | 02/25/1997SE |
| K961791 | Depuy Disposable Filter/HoodLYU · Traditional | Depuy, Inc. | 08/09/1996SE |
| K961454 | Ammi Magni-GuardLYU · Traditional | American Medical Mfg., Inc. | 07/25/1996SE |
| K945302 | Sloan Sta-Dri Pant ProtectorLYU · Traditional | Sloan Corp. | 03/19/1996SE |
| K954314 | Ultrafit LinersLYU · Traditional | Stahmer Weston Scientific | 12/28/1995SE |
| K953089 | I-SpouseLYU · Traditional | Products For Medicine | 10/16/1995SE |
| K952303 | Splash AssistLYU · Traditional | Innovative Outsourcing Solutions | 08/24/1995SE |
More from Innovative Outsourcing Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K970547 | Isolyser SDS Sharps ContainerFMI · Traditional | 07/18/1997SE |
| K961083 | Orex Surgeon's VestFYA · Traditional | 08/23/1996SE |
| K943626 | Isolyser Sharps Management System SMSFMI · Traditional | 06/16/1995SE |
| K945755 | Orex(R) O.R Equipment DrapesKKX · Traditional | 05/25/1995SE |
| K945223 | Orex Isolation GownFYC · Traditional | 04/25/1995SE |
| K944859 | Orex Surgical DrapesKKX · Traditional | 02/28/1995SE |
| K944827 | Orex Surgeon's GownFYA · Traditional | 02/28/1995SE |
| K943034 | Orex Shoe CoversFXP · Traditional | 01/02/1995SE |
| K942228 | Orex O.R. TowelKKX · Traditional | 12/20/1994SE |
| K940767 | Orex (12X12 X-Ray Detectable)GDY · Traditional | 12/19/1994SE |
Questions and answers
When was Isolyser Orex Surgeon's Caps, Hoods, Bouffant Caps cleared by the FDA?
Isolyser Orex Surgeon's Caps, Hoods, Bouffant Caps (K942200) received a 510(k) decision of Substantially Equivalent on August 7, 1995, 459 days after the submission was received.
What is the product code of K942200?
The FDA product code is LYU – Accessory, Surgical Apparel, a Class I (low risk) device regulated under 21 CFR 878.4040.