Boundary Single-Use Gowns
by Procter & Gamble Mfg. Co. 510(k)
Active
510(k) K834332
Overview
The Boundary Single-Use Gowns are classified as surgical gowns, designed for single-use in clinical settings. These gowns provide a barrier to protect healthcare personnel and patients from contamination during medical procedures, adhering to regulatory standards for disposable protective apparel. Constructed from plastic materials, they are intended to minimize cross-contamination risks in surgical environments. Their design aligns with the definition of a gown under the FDA’s classification system for medical devices.
These gowns are supplied as single-use items, ensuring sterility and reducing the risk of infection transmission. They are regulated under FDA 510(k) clearance (K834332) and fall under the product code FYA, classified as Class II devices. No additional regulatory approvals beyond the 510(k) clearance are stated in the data. Storage and handling should comply with standard sterile barrier precautions for single-use medical apparel, though specific storage conditions are not detailed in the provided specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK834332 | Date1 May 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Procter & Gamble Co.
Questions
Are these gowns intended for reuse or are they strictly single-use?
These gowns are explicitly designed for single-use only. The manufacturer emphasizes their sterile, disposable nature to minimize contamination risks in clinical settings, ensuring each gown is used once and then discarded.
What types of clinical environments are these gowns primarily intended for?
The gowns are classified as surgical gowns and are intended for use in clinical settings where contamination protection is critical, such as surgical environments. Their design aligns with FDA standards for disposable protective apparel to reduce cross-contamination risks during medical procedures.
How should these gowns be stored to maintain their integrity?
While specific storage conditions aren’t detailed, as single-use sterile items, these gowns should be stored following standard sterile barrier precautions for medical apparel. This typically includes keeping them in sealed packaging, away from moisture, direct sunlight, and extreme temperatures to preserve sterility and prevent contamination.
What regulatory pathway was followed for clearance of these gowns?
The gowns were cleared through the FDA’s 510(k) process (traditional pathway, K-number K834332), with a decision of *Substantially Equivalent* (SESE) to a predicate device. They fall under product code FYA and are classified as Class II devices, with no additional regulatory approvals mentioned beyond this clearance.
Are these gowns made from a specific material, and what does that mean for their performance?
The gowns are constructed from plastic materials, which provides a barrier against liquids and contaminants. This material choice helps reduce the risk of cross-contamination in surgical settings, aligning with their purpose as disposable protective apparel for healthcare personnel and patients.