Suit, Surgical
FDA 510(k) K882282 · A Plus International, Inc.
510(k) numberK882282
Submission
- Device name
- Suit, Surgical
- Applicant
- A Plus International, Inc.
La Puente, CA, US - Received
- May 31, 1988
- Decision date
- June 23, 1988
- 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 |
| K891212 | Aprons, Scrubs Slacks & Tops, Patient DrapeFXO · Traditional | Pro-Safe Professional Linens, Inc. | 04/14/1989SE |
| 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 |
|---|---|---|
| K213001 | Procedure Mask, Surgical MaskFXX · Traditional | 05/11/2022SE |
| K102861 | Surgiplus SMS Surgical Drape (Sterile/Non-Sterile), Surgiplus SPP with Pe Laminated…KKX · Traditional | 01/13/2011SE |
| K093169 | Surgiplus Standard Surgical Gown (Sterile) ( Non Sterile), Reinforced Surgical Gown…FYA · Traditional | 11/12/2009SE |
| K031353 | Solution Face MasksFXX · Traditional | 06/19/2003SE |
| K882284 | Surgeons CapFYF · Traditional | 06/23/1988SE |
| K882283 | Bouffant CapFYF · Traditional | 06/23/1988SE |
| K882281 | Gown, Isolation, Surgical (Fyc)FYC · Traditional | 06/23/1988SE |
| K882280 | Cover, Shoe Operating RoomFXP · Traditional | 06/23/1988SE |
| K881396 | Operating Room Towels -Sterile & Non-SterileKKX · Traditional | 04/29/1988SE |
| K881395 | Gauze and Lap Sponges -Sterile & Non-SterileEFQ · Traditional | 04/28/1988SE |
Questions and answers
When was Suit, Surgical cleared by the FDA?
Suit, Surgical (K882282) received a 510(k) decision of Substantially Equivalent on June 23, 1988, 23 days after the submission was received.
What is the product code of K882282?
The FDA product code is FXO – Suit, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4040.