Deseret Multilumen Subclavian Catheter
FDA 510(k) K895735 · Deseret Medical, Inc.
510(k) numberK895735
Submission
- Device name
- Deseret Multilumen Subclavian Catheter
- Applicant
- Deseret Medical, Inc.
Sandy, UT, US - Received
- September 27, 1989
- Decision date
- May 18, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LYY – Latex Patient Examination Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Other 510(k)s with product code LYY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250069 | Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein…LYY · Traditional | Comfort Rubber Gloves Industries Sdn. Bhd. | 04/29/2025SE |
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural White)LYY · Abbreviated | Sri Trang Gloves (Thailand) Public Company Limited | 09/09/2024SE |
| K230573 | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein…LYY · Traditional | Kossan International Sdn Bhd | 06/13/2023SE |
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)LYY · Traditional | Shandong Intco Medical Products Co, Ltd. | 02/22/2023SE |
| K222612 | Powder-Free Latex examination glovesLYY · Traditional | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 11/25/2022SE |
| K221667 | Non Sterile Powder Free Latex Examination GloveLYY · Traditional | New Era Medicare Sdn. Bhd. | 10/28/2022SE |
| K222348 | JR MedicLYY · Abbreviated | Jr Engineering & Medical Technologies (M) Sdn.… | 10/27/2022SE |
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)LYY · Traditional | Hebei Titans Hongsen Medical Technology Co., Ltd. | 10/26/2022SE |
| K222693 | Single-use medical latex examination gloves (LG100)LYY · Traditional | Fitone Latex Products Co., Ltd. Guangdong | 09/24/2022SE |
| K221648 | Iconic Latex GloveLYY · Traditional | Iconic Medicare Sdn Bhd | 08/25/2022SE |
More from Iconic Medicare Sdn Bhd
| 510(k) | Device | Decision |
|---|---|---|
| K913027 | Vessel DilatorDRE · Traditional | 11/27/1991SE |
| K904648 | Safe Syte I.V. Catheter Placement UnitFOZ · Traditional | 12/14/1990SE |
| K904121 | Vialon ObturatorFOZ · Traditional | 11/08/1990SE |
| K904122 | Insyte-A Arterial Catheterization UnitFOZ · Traditional | 10/04/1990SE |
| K900116 | Deseret Optima Intravascular CatheterFOZ · Traditional | 06/18/1990SE |
| K895734 | Deseret Intravascular CatheterFOZ · Traditional | 04/09/1990SE |
| K894033 | Disposable Catheter Pressure TransducerDXO · Traditional | 10/17/1989SE |
| K893406 | Deseret PRN AdapterKGZ · Traditional | 06/22/1989SE |
| K882798 | Multiflo AdapterFPA · Traditional | 07/18/1988SE |
| K882797 | Luer-Lok Multiflo AdapterFPA · Traditional | 07/18/1988SE |
Questions and answers
When was Deseret Multilumen Subclavian Catheter cleared by the FDA?
Deseret Multilumen Subclavian Catheter (K895735) received a 510(k) decision of Substantially Equivalent on May 18, 1990, 233 days after the submission was received.
What is the product code of K895735?
The FDA product code is LYY – Latex Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.