Medline Sterilization Wrap
510(k) K002968
Medline Sterilization Wrap is a Class II device made by Medline Industries, Inc., cleared under FDA 510(k) K002968 on 23 Jan 2001, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK002968 | Date23 Jan 2001 | StatusActive |
Official records
- FDA 510(k) database K002968
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FRG
- Device class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
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Other devices filed under FDA product code FRG (Wrap, Sterilization).
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- STERI-STOR TM by Research Surgical Systems
- AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER by AESCULAP, INC.
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- SKIN SCRUB TRAY STERILE SKIN SCRUB KIT by Biological & Environmental Control Laboratories
- AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE by Amsco Sterile Recoveries, Inc.
- CareGUARD Sterilization Wrap by CARE ESSENTIALS PTY LTD