84E Series Single Ply Wrapper
FDA 510(k) K102864 · Lac Mac, Ltd.
510(k) numberK102864
Submission
- Device name
- 84E Series Single Ply Wrapper
- Applicant
- Lac Mac, Ltd.
Austin, TX, US - Received
- September 30, 2010
- Decision date
- January 14, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K092344 | Lac-Mac Innerbloc LR Surgical GownsFYA · Abbreviated | 12/17/2009SE |
| K061491 | Lac-Mac Innerbloc O.R. GownFYA · Abbreviated | 08/09/2006SE |
| K032631 | Innerbloc LR Surgical Gowns Based on Gore LR Fabric (Reusable 100X)FYA · Traditional | 02/05/2004SE |
| K031362 | Lac-Mac Limited Innerbloc Various O.R. Drape Based on the Repel, Plus and Gore Surgical…KKX · Traditional | 05/30/2003SE |
| K030536 | Lac-Mac Limited Innerbloc O.R. GownFYA · Traditional | 05/06/2003SE |
Questions and answers
When was 84E Series Single Ply Wrapper cleared by the FDA?
84E Series Single Ply Wrapper (K102864) received a 510(k) decision of Substantially Equivalent on January 14, 2011, 106 days after the submission was received.
What is the product code of K102864?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.