Absorbable Gauze Drape
by Ulti-Med Intl., Inc. 510(k)
Active
510(k) K901465
Overview
The Absorbable Gauze Drape is a Class I surgical drape designed for wound coverage and protection during procedures. Constructed from an absorbable material, it is intended to provide temporary hemostasis and absorb exudate while maintaining a sterile field. This device is classified under FDA regulation number 878.4440, falling under the general category of plastic surgery aids.
Supplied as a single-use item, the Absorbable Gauze Drape is intended for use in surgical settings where absorbable wound coverage is required. It is not intended for MRI environments and must be stored in a clean, dry place until use. The device holds FDA 510(k) clearance (K901465) under the Traditional 510(k) review pathway, with a decision date of June 12, 1990, and is classified as substantially equivalent to the predicate device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK901465 | Date12 Jun 1990 | 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- Withdrawn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
- KKX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Ulti-Med Intl., Inc.
Questions
What is the Absorbable Gauze Drape used for?
The Absorbable Gauze Drape is designed for surgical wound coverage and protection during procedures. Its absorbable material helps achieve temporary hemostasis and absorbs exudate, while also maintaining a sterile field. This makes it ideal for situations where a temporary, self-dissolving barrier is needed without leaving residual synthetic material.
Is the Absorbable Gauze Drape single-use or reusable?
The Absorbable Gauze Drape is explicitly supplied as a single-use item. This ensures sterility and prevents cross-contamination between patients, as reusable items would require cleaning and reprocessing, which could compromise the absorbable properties and integrity of the material.
How should the Absorbable Gauze Drape be stored?
The device must be stored in a clean, dry place until use. Proper storage conditions are critical to maintain its sterility and absorbable characteristics. Avoid exposure to moisture or extreme temperatures, as these could degrade the material or alter its performance during surgery.
Can the Absorbable Gauze Drape be used in MRI environments?
No, the Absorbable Gauze Drape is explicitly not intended for use in MRI environments. This is likely due to the material composition, which may not be MRI-compatible. Always verify device compatibility with imaging modalities before use to avoid interference or safety risks.
What regulatory pathway was used for FDA clearance?
The Absorbable Gauze Drape received FDA clearance under the Traditional 510(k) review pathway, with a decision date of June 12, 1990. It was classified as substantially equivalent to a predicate device, meaning the FDA determined it had the same intended use and technological characteristics as an existing approved product. The clearance number is K901465.