Surgical Gown (AE1001, AE2001, AE3001; AG1001, AG2001, AG3001)
510(k) K172987
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172987 | Date13 Jul 2018 | 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- Withdrawn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
- Full name
- Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)
- 510(k) Number
- FDA Product Code
- FYA
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a surgical gown, classified under product code FYA, designed to provide barrier protection during surgical procedures. It is intended to shield both the patient and operating room personnel from contamination by microorganisms, body fluids, and particulate matter, ensuring a sterile field and reducing cross-transmission risks.
The gowns are supplied as single-use, sterile barrier garments, intended for use in operating rooms and sterile environments. They comply with FDA 510(k) clearance (K172987) under the Traditional 510(k) Review pathway and are categorized under the General and Plastic Surgery advisory committee. No MRI safety or reusable specifications are indicated in the regulatory submission.
Questions
AI-generated answers, 19 Sep 2026
Are these surgical gowns intended for reuse in multiple procedures, or are they designed for single-use only?
These surgical gowns are explicitly designed for single-use only. The product description and specifications confirm they are supplied as sterile barrier garments meant to be discarded after one use to maintain sterility and prevent contamination risks during surgical procedures.
What types of surgical environments or procedures are these gowns primarily intended for?
These gowns are intended for use in operating rooms and sterile environments where contamination control is critical. They provide barrier protection for both patients and personnel against microorganisms, body fluids, and particulate matter, ensuring a sterile field during surgical procedures.
How are the gowns packaged and stored to maintain sterility before use?
While the exact packaging details aren’t specified, the gowns are sterile barrier garments by design, implying they are likely packaged in sealed, sterile wrappers or pouches. To preserve sterility, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use.
Are there different sizes or models available, and if so, how do they differ?
Yes, these gowns come in multiple models: AE1001, AE2001, AE3001 (one set of variants) and AG1001, AG2001, AG3001 (another set). While the exact size differences (e.g., sizing for adult or pediatric use, length, or fit) aren’t detailed in the data, the numbering suggests variations in design or features tailored for different procedural needs or user preferences.
What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed this submission?
These gowns were cleared through the Traditional 510(k) Review pathway under the General and Plastic Surgery advisory committee (reviewed by the HO Subcommittee). The clearance number is K172987, and the decision was made on July 13, 2018, confirming they meet FDA standards for surgical gowns classified under product code FYA.