Shirt, Operating, Surgical
510(k) K894599
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK894599 | Date11 Aug 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FYA
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Shirt, Operating, Surgical is a disposable protective garment designed for use during surgical procedures. It provides a sterile barrier between the patient and the surgical team, helping to maintain aseptic conditions and reduce the risk of contamination. Constructed from medical-grade materials, it is intended to cover the torso and arms of the surgical staff, ensuring comfort and mobility while adhering to infection control protocols. This device falls under the category of surgical apparel, specifically tailored for operating room environments.
This device is supplied as a single-use item, ensuring sterility and compliance with surgical standards. It is intended for use in sterile operating room settings and must be discarded after a single procedure to prevent cross-contamination. The product is regulated under the FDA’s 510(k) clearance process, with the specific filing identified as K894599. No additional regulatory markings or MRI safety classifications are indicated in the available data. Storage should follow manufacturer guidelines to preserve sterility and integrity prior to use.
Other devices from Miroz Industries Co.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the Surgical Operating Shirt by Miroz Industries?
The Surgical Operating Shirt is designed as a disposable protective garment for surgical staff during procedures. Its main function is to create a sterile barrier between the patient and the team, reducing contamination risks while maintaining aseptic conditions in the operating room. The medical-grade materials also prioritize comfort and mobility for extended wear.
Is this shirt intended for reuse or single-use, and why?
This shirt is strictly for single-use only. The disposable design ensures sterility is maintained throughout a single surgical procedure, preventing cross-contamination between patients. Reuse could compromise the sterile barrier, violating infection control protocols and potentially exposing patients to pathogens.
How should the Surgical Operating Shirt be stored before use?
Storage must follow the manufacturer’s guidelines to preserve sterility and integrity. Typically, this involves keeping the shirt in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoiding contamination or physical damage ensures the garment remains effective for its intended surgical use.
What regulatory pathway does this device follow, and what does that mean for users?
The device is cleared under the FDA’s 510(k) process, specifically filing K894599, with a decision labeled as ‘Substantially Equivalent’ to a predicate device. This means it meets FDA standards for safety and effectiveness as determined by a review panel (General, Plastic Surgery Advisory Committee). Users can rely on this clearance as confirmation that the product adheres to regulatory requirements for surgical apparel.
Does this shirt have any special considerations for operating room environments?
Yes, the shirt is tailored for sterile operating room settings and must be discarded after a single procedure. Its design ensures coverage of the torso and arms while allowing mobility, which is critical for surgical staff during prolonged procedures. The disposable nature aligns with infection control protocols to minimize risks associated with reusable textiles.