Gent-L-Kare Laceration Trays
FDA 510(k) K950850 · Premium Plastics, Inc.
510(k) numberK950850
Submission
- Device name
- Gent-L-Kare Laceration Trays
- Applicant
- Premium Plastics, Inc.
Chicago, IL, US - Received
- February 24, 1995
- Decision date
- March 14, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRG – Wrap, Sterilization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
Other 510(k)s with product code FRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…FRG · Traditional | O&M Halyard, Inc. | 07/02/2026SE |
| K252823 | Dukal Crepe Paper Sterilization WrapFRG · Traditional | Dukal, LLC | 05/28/2026SE |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…FRG · Traditional | O&M Halyard, Inc. | 05/18/2026SE |
| K251347 | Sterilization Pouch/RollFRG · Traditional | Sterivic Medical Co., Ltd. | 01/28/2026SE |
| K251177 | Self-Seal Sterilization Pouch and RollFRG · Traditional | Guangdong Maidi Medical Co., Ltd. | 12/12/2025SE |
| K250306 | Chex-All Sterilization Pouches and TubesFRG · Abbreviated | Propper Manufacturing Co., Inc. | 10/31/2025SE |
| K243179 | Sterilization Pouch and RollFRG · Traditional | Yichang Xinxin Paper Products Co., Ltd. | 06/26/2025SE |
| K250321 | GCI Sterilization WrappersFRG · Traditional | George Courey, Inc. | 06/06/2025SE |
| K243721 | Self Sealing Sterilization PouchesFRG · Traditional | Wellmed Dental Medical Supply Co., Ltd. | 04/25/2025SE |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…FRG · Traditional | Turbett Surgical | 04/04/2025SE |
More from Turbett Surgical
| 510(k) | Device | Decision |
|---|---|---|
| K953226 | Pulm O2 Suction Catheter TraysBSY · Traditional | 08/08/1995SE |
| K950851 | Gent-L-Kare Tracheostomy TraysLRQ · Traditional | 06/21/1995SE |
| K943740 | Roll-A-Way Sharps Disposal System (Red and Ivory)FMI · Traditional | 12/14/1994SE |
| K890107 | Gent-L-Kare(Tm) Sterile, Pressure Sore Manage KitFRO · Traditional | 10/24/1989SESD |
| K893135 | Gent-L-Kare Ster Suct Cath Tray W/14 Fr/Ster WaterJOL · Traditional | 06/22/1989SE |
| K850285 | Gent-L-Kare Sterile Urethral Catheterization TrayKOD · Traditional | 02/28/1985SE |
| K800440 | Sterile Sponge BowlsFNY · Traditional | 04/29/1980SE |
| K771448 | Sterile Suture Removal KitKDD · Traditional | 09/06/1977SE |
Questions and answers
When was Gent-L-Kare Laceration Trays cleared by the FDA?
Gent-L-Kare Laceration Trays (K950850) received a 510(k) decision of Substantially Equivalent for Some Indications on March 14, 1995, 18 days after the submission was received.
What is the product code of K950850?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.