Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6850](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6850) → FRG — Wrap, Sterilization

# FRG · Wrap, Sterilization

_General Hospital · 21 CFR 880.6850 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/FRG

## Overview

- **Product Code:** FRG
- **Device Name:** Wrap, Sterilization
- **Regulation:** [21 CFR 880.6850](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6850)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)
- **3rd-party reviewable:** yes

## Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 322)

Showing 20 most recent of 322 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252823](/device/K252823.md) | Dukal Crepe Paper Sterilization Wrap | Dukal, LLC | May 28, 2026 | SESE |
| [K253454](/device/K253454.md) | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL  Sterilization Wrap; HALYARD* SMART-FOLD*  Sterilization Wrap | O&M Halyard, Inc. | May 18, 2026 | SESE |
| [K251347](/device/K251347.md) | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. | Jan 28, 2026 | SESE |
| [K251177](/device/K251177.md) | Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co., Ltd. | Dec 12, 2025 | SESE |
| [K250306](/device/K250306.md) | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | Oct 31, 2025 | SESE |
| [K243179](/device/K243179.md) | Sterilization Pouch and Roll | Yichang Xinxin Paper Products Co., Ltd. | Jun 26, 2025 | SESE |
| [K250321](/device/K250321.md) | GCI Sterilization Wrappers | George Courey, Inc. | Jun 6, 2025 | SESE |
| [K243721](/device/K243721.md) | Self Sealing Sterilization Pouches | Wellmed Dental Medical Supply Co., Ltd. | Apr 25, 2025 | SESE |
| [K250011](/device/K250011.md) | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | Turbett Surgical | Apr 4, 2025 | SESE |
| [K241565](/device/K241565.md) | Sterilization Package/Reel | Anqing Clean Dental Instrument Technology Co., Ltd. | Feb 24, 2025 | SESE |
| [K243431](/device/K243431.md) | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | Feb 21, 2025 | SESE |
| [K242898](/device/K242898.md) | Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. | Feb 21, 2025 | SESE |
| [K240438](/device/K240438.md) | CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) | Comercializadora Brever | Nov 4, 2024 | SESE |
| [K242839](/device/K242839.md) | Safe Secure Sterilization Pouches and Rolls | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | Oct 16, 2024 | SESE |
| [K242208](/device/K242208.md) | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | Oct 7, 2024 | SESE |
| [K241123](/device/K241123.md) | Perpak™ Sterilization Tyvek Pouch | Km Corp. | Sep 18, 2024 | SESE |
| [K234132](/device/K234132.md) | Medline Reusable Sterilization Wrappers | Medline Industries, LP | Sep 17, 2024 | SESE |
| [K234050](/device/K234050.md) | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap | O&M Halyard, Inc. | Sep 16, 2024 | SESE |
| [K240330](/device/K240330.md) | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) | O&M Halyard, Inc. | Aug 7, 2024 | SESE |
| [K240862](/device/K240862.md) | Medicom Sterilization Wrap | Medicom Group, Inc. | Jun 21, 2024 | SESE |

## Top Applicants

- Cardinal Health200, LLC — 11 clearances
- Kimberly-Clark Corp. — 11 clearances
- Case Medical, Inc. — 9 clearances
- Medline Industries, Inc. — 9 clearances
- Custom Pack Reliability — 7 clearances

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**Source:** [https://fda.innolitics.com/productcode/FRG](https://fda.innolitics.com/productcode/FRG)

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