Bouffant Cap
FDA 510(k) K882283 · A Plus International, Inc.
510(k) numberK882283
Submission
- Device name
- Bouffant Cap
- 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
- FYF – Cap, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FYF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972227 | Shoe CoverFYF · Traditional | American Seal Co. | 09/09/1997SE |
| K955833 | Niomed Surgical CapsFYF · Traditional | Amerasia Corp. | 03/15/1996SE |
| K954556 | Surgical CapFYF · Traditional | Thai Disposable Products Co., Ltd. | 03/12/1996SE |
| K954455 | Niomed Bouffant CapsFYF · Traditional | Amerasia Corp. | 01/23/1996SE |
| K954454 | Niomed Surgical HoodFYF · Traditional | Amerasia Corp. | 01/23/1996SE |
| K953879 | Surgeon's CapFYF · Traditional | American Threshold Industries, Inc. | 01/05/1996SE |
| K953878 | Bouffant CapFYF · Traditional | American Threshold Industries, Inc. | 01/05/1996SE |
| K913700 | Disposable Bouffant CapFYF · Traditional | Gem Nonwovews, Inc. | 10/04/1991SE |
| K882346 | Instrument Protect-A-Caps, Aka: Tip/Instru. GuardFYF · Traditional | Nordbye, Milchman, Barlage | 06/30/1988SE |
| K882284 | Surgeons CapFYF · Traditional | A Plus International, Inc. | 06/23/1988SE |
More from A Plus International, 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 |
| K882282 | Suit, SurgicalFXO · 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 Bouffant Cap cleared by the FDA?
Bouffant Cap (K882283) 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 K882283?
The FDA product code is FYF – Cap, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4040.