Aprons, Scrubs Slacks & Tops, Patient Drape
FDA 510(k) K891212 · Pro-Safe Professional Linens, Inc.
510(k) numberK891212
Submission
- Device name
- Aprons, Scrubs Slacks & Tops, Patient Drape
- Applicant
- Pro-Safe Professional Linens, Inc.
Grand Junction, CO, US - Received
- March 7, 1989
- Decision date
- April 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FXO – Suit, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914615 | Btp(Tm) Centraline(Tm) SuitFXO · Traditional | Btp Industries, Inc. | 05/05/1992SE |
| K882282 | Suit, SurgicalFXO · Traditional | A Plus International, Inc. | 06/23/1988SE |
| K865022 | Surgical GarmentsFXO · Traditional | Ulti-Med Intl., Inc. | 01/12/1987SE |
| K831207 | Spunguard Scrub SuitFXO · Traditional | Kimberly-Clark Corp. | 05/16/1983SE |
| K822483 | Multiple Scrub SuitFXO · Traditional | Surgilite Intl., Inc. | 09/17/1982SE |
More from Surgilite Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K891210 | Pocketed Wraps #3009 A,B,CKCT · Traditional | 10/13/1989SE |
| K891216 | Dental Equipment Protection DevicesEAZ · Traditional | 06/02/1989SE |
| K891215 | Fast Wrap #M 101KCT · Traditional | 04/14/1989SE |
| K891214 | Dental Surgical Wrap #3007 A,B,CKCT · Traditional | 04/14/1989SE |
| K891213 | Surgical Instrument Pouch #M102KCT · Traditional | 04/14/1989SE |
| K891211 | Surgical Gown #2001FYA · Traditional | 04/14/1989SE |
Questions and answers
When was Aprons, Scrubs Slacks & Tops, Patient Drape cleared by the FDA?
Aprons, Scrubs Slacks & Tops, Patient Drape (K891212) received a 510(k) decision of Substantially Equivalent on April 14, 1989, 38 days after the submission was received.
What is the product code of K891212?
The FDA product code is FXO – Suit, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4040.