Caretex Central Supply Wrap
FDA 510(k) K883802 · James River Corp.
510(k) numberK883802
Submission
- Device name
- Caretex Central Supply Wrap
- Applicant
- James River Corp.
Neenah, WI, US - Received
- September 7, 1988
- Decision date
- October 21, 1988
- Decision
- Substantially Equivalent (SESE)
- 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 |
|---|---|---|
| K894505 | Cotolin Drain Sponge and Dressing SpongeEFQ · Traditional | 09/15/1989SE |
| K894147 | Visulin Transparent Adhesive DressingKGX · Traditional | 08/09/1989SN |
| K894034 | Modified Labeling of Surgical GlovesKGO · Traditional | 07/14/1989SE |
| K893939 | Isolation MasksFXX · Traditional | 07/14/1989SE |
| K892580 | Caretouch Examination GlovesLYY · Traditional | 07/14/1989SE |
| K890459 | James River Biogel Powderless Surgical GlovesKGO · Traditional | 04/20/1989SE |
| K884112 | Caretex or TowelKKX · Traditional | 10/13/1988SE |
| K883657 | Skid Resistant, Long Lasting Shoe CoversFXP · Traditional | 09/15/1988SE |
| K880481 | Caretex Surgeon's CapsFYF · Traditional | 02/24/1988SE |
| K880431 | Caretex Surgeon's HoodsFXY · Traditional | 02/24/1988SE |
Questions and answers
When was Caretex Central Supply Wrap cleared by the FDA?
Caretex Central Supply Wrap (K883802) received a 510(k) decision of Substantially Equivalent on October 21, 1988, 44 days after the submission was received.
What is the product code of K883802?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.