Disposable Isolation Gown
FDA 510(k) K911921 · Liaoning-Usa Corp.
510(k) numberK911921
Submission
- Device name
- Disposable Isolation Gown
- Applicant
- Liaoning-Usa Corp.
Pasadena, CA, US - Received
- April 30, 1991
- Decision date
- May 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FYB – Gown, Patient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891820 | Disposable Medical GownsFYB · Traditional | Bioshield, Inc. | 07/24/1989SE |
| K891053 | Dental BibFYB · Traditional | Dispomed, Inc. | 04/12/1989SE |
| K803171 | Procedure & Recovery Patient SuitFYB · Traditional | Alba Health Care | 03/04/1981SE |
| K801570 | Shield Disp. Patients Poncho GownsFYB · Traditional | American Convertors Div., American Pharmaseal | 07/28/1980SE |
| K771929 | Pediatrics GownFYB · Traditional | Convertors | 11/16/1977SE |
More from Convertors
| 510(k) | Device | Decision |
|---|---|---|
| K905487 | Various Types of StethoscopesLDE · Traditional | 04/09/1991SE |
| K910623 | Gauze Sponges Absorbent Gauze RollsEFQ · Traditional | 04/01/1991SE |
| K902625 | Clinical Thermometer; Rectal/Oral, Inner ArmpitFLK · Traditional | 10/26/1990SE |
| K892781 | Antelope Brand Patient Examination GlovesLYY · Traditional | 09/21/1989SE |
| K892774 | Patient Examination GlovesLYY · Traditional | 09/13/1989SE |
Questions and answers
When was Disposable Isolation Gown cleared by the FDA?
Disposable Isolation Gown (K911921) received a 510(k) decision of Substantially Equivalent on May 13, 1991, 13 days after the submission was received.
What is the product code of K911921?
The FDA product code is FYB – Gown, Patient, a Class II (moderate risk) device regulated under 21 CFR 878.4040.